aromatherapy for preoperative anxiety among female breast

Medical University of South Carolina Medical University of South Carolina

MEDICA MEDICA

MUSC Theses and Dissertations

2016

Aromatherapy for Preoperative Anxiety among Female Breast Aromatherapy for Preoperative Anxiety among Female Breast

Surgery Patients: A Feasibility Study Surgery Patients: A Feasibility Study

Candace B. Jaruzel Medical University of South Carolina

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Recommended Citation Recommended Citation Jaruzel, Candace B., "Aromatherapy for Preoperative Anxiety among Female Breast Surgery Patients: A Feasibility Study" (2016). MUSC Theses and Dissertations. 399. https://medica-musc.researchcommons.org/theses/399

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TABLEOFCONTENTSLISTOFTABLES.......................................................................................................................................................4LISTOFFIGURES.....................................................................................................................................................5LISTOFAPPENDICES............................................................................................................................................6ACKNOWLEDGEMENTS.......................................................................................................................................7ABSTRACT..................................................................................................................................................................9INTRODUCTION....................................................................................................................................................11MANUSCRIPTI......................................................................................................................................................19MANUSCRIPTII.....................................................................................................................................................38MANUSCRIPTIII...................................................................................................................................................53CONCLUSION/SUMMARY..................................................................................................................................81APPENDICES...........................................................................................................................................................84

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LISTOFTABLES

TABLEI:Principle-basedConceptAnalysis..............................................................................................33TABLEII:Dataextractionandpsychometricproperties....................................................................49TABLEIII:Demographicsoffemalebreastsurgeryparticipants....................................................73TABLEIV:RE-AIMdimensionsforevaluatingfeasibility...................................................................74TABLEV:Comparisonusingpairedsamplestestforbaselineandfinalmeasurements......77

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LISTOFFIGURES

FIGUREI:DataSourcesFlowChart..............................................................................................................33FIGUREII:TheStressResponseTheory.....................................................................................................47

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LISTOFAPPENDICESAPPENDIXI:ParticipantFollowUpPhoneCallQuestionnaire........................................................78APPENDIXII:ProviderREDCapPost-StudySurvey..............................................................................79APPENDIXIII:VisualAnalogScale…............................................................................................................80APPENDIXIV:ProtocolReviewCommitteeLetterofApproval.......................................................85APPENDIXV:InstitutionalReviewBoardLetterofApproval..........................................................87APPENDIXVI:ConsentForm...........................................................................................................................88APPENDIXVII:HIPPAFORM...........................................................................................................................92

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Acknowledgements

Iwouldfirstliketoexpressmysincereappreciationandgratitudetomy

dissertationcommittee,Dr.TeresaKelechi,Dr.MartinaMueller,Dr.MatGregoski,andDr.

AmandaFaircloth.Youhaveallmentored,guided,supported,inspiredandencouragedme,

inyourownway,throughmyPhDjourney.Eachofyoupossessesagenuinepassionfor

researchandacommitmenttoexcellencethatIvalueandwillcarrywithmeasItakemy

nextstepsasanursingscientist.

Ihavereceivedinvaluablesupportfrommanyfaculty,staff,andclinicians.Iwould

liketothankthetechnicallysavvy,MobyMadesettiforhisknowledgeandassistancewith

myIRBsubmissionandREDCapdatabasecreationandBernieJansenforhiscomputer

expertise.TotheAshleyRiverTowerpreoperativeregisterednurses,Becky,Debbie,

Dianne,Kathy,Kelly,Linda,Marie,andMichele,Icouldnothavedoneitwithoutallofyour

support.Thankyouallforembracingmyeducationalendeavorandresearch.Iwouldalso

liketothankmyco-investigators,Dr.Demore,Dr.Abbott,Dr.Cole,andDr.Lockett.

Tomydearfriendsandcolleagues,Dawn,Wilson,Marianne,Donna,Rachel,Rich,

Karin,Jennifer,Angie,MickiandLisa,therearesimplynowordstoexpresshowgratefulI

amtohaveallofyoubymyside.Thankyouallforyourencouragement,support,andfor

listeningandbeingtherewhenIneededyoumost.

Finally,thisjourneywouldnothavebeenpossiblewithouttheunwaveringlove,

encouragement,andsupportIhavereceivedfrommyfamily.Ron,mywonderfulhusband,I

greatlyappreciateallthesacrificesyouhavemadeformysuccessandIloveyouwithall

myheart.AnistonandCaroline,mybeautifuldaughters,IloveyoumydoodlebugsandI

willalwaystreasureallthe“PhD”picturesyoumade,notesofencouragementyougaveme,

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andtheplaytimewehadin“mommy’sPhDoffice”.Mom,Dad,Scott,Sarah,Cameron,Ms.

Sue,Mr.Ronandallofmyextendedfamily,thankyouforbelievinginme.Allofyouinspire

mesoIwillendwithaninspirationalquotefromSirIsaacNewton.

“IfIhaveseenfartherthanothers,

itisbecauseIwasstandingontheshouldersofgiants”

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Abstract

Purpose:Thisdissertationaddressestheuseofcomplementarytherapiesinthe

perioperativeperiodforacutesituationalanxiety.Theaimofthisdissertationwasto

exploretheconceptofrelieffromanxiety,todescribeinstrumentsusedtomeasure

preoperativeanxiety,andtoevaluatethefeasibilityofusingaromatherapypatchfor

preoperativeanxietyamongfemalebreastsurgerypatients.

Design:Thisdissertationincludesaprinciple-basedconceptanalysisonrelieffromanxiety

usingcomplementarytherapiesintheperioperativeperiod,anintegrativereviewon

instrumentsusedtomeasurepreoperativeacutesituationalanxiety,andafeasibilitystudy

usingtheRE-AIMframeworktoevaluatethefeasibilityofprovidinglavender

aromatherapythroughasustained-releasepatchandtheuseofaVisualAnalogScale(VAS)

tomeasureanxietylevelsduringthepreoperativeperiodforfemalebreastsurgery

patients.

Conclusions:Thisdissertationprovidesagreaterunderstandingofrelieffromanxiety

usingcomplementarytherapies.Thisknowledgewillallowperioperativeprovidersto

modifyandspecifytheincorporationofcomplementarytherapiestotheplanofcarefor

surgicalpatientsexperiencingacutesituationalanxiety.However,ifproviderswishto

implementaplanofcareforpreoperativeacutesituationalanxiety,areliableandvalid

instrumentshouldbeusedformeasurement.Afeasibleandconvenientoptionfor

measuringandtreatingpreoperativeanxietyareaVASandasustained-releaselavender

aromatherapypatch.

ClinicalRelevance:Theideasforthisdissertationarosedirectlyfrommyclinicalpracticeas

aCertifiedRegisteredNurseAnesthetistandmypersonalappreciationfortheuseof

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complementarytherapiestorelieveorreduceanxietyorstress.Numerousdeleterious

effectscanoccurfromuntreatedanxietyintheperioperativeperiod.Therefore,this

dissertationexploresoptions,beyondthetraditionalanxietytreatment,forpatientsand

providerstouseforperioperativeanxiety.Aromatherapywasshowntobeafeasibleand

potentiallyefficaciousinterventiontoreducepreoperativeanxiety.Thenextstepisto

conductarandomizedcontrolledtrialtodeterminewhetherthearomatherapypatch

demonstratesefficacycomparedtoaplacebopatchonperceivedreductionsandbio-

behavioraldecreasesinanxiety(i.e.,anxietyscales,heartratevariability,skinconductance,

physiologicalbiomarkersofstress)amongpatientsinthepreoperativeperiod.

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Introduction

Anxietyisaubiquitousprobleminthehealthcaresetting.Thefocusofthis

dissertationisacutesituationalanxietyamongsurgicalpatients,specificallyfemale

patientsundergoingbreastsurgery,inthepreoperativeperiod.Acutesituationalanxietyis

asubjectivefeelingofanunpleasant,fearfulemotionoruneasinessthatisinfluencedbyan

immediatesituation(Acar,Cuvas,Ceyhan,&Dikmen,2013,Maranets&Kain,1999,

Merriam-Webster.com,2015,Waltz,Strickland,&Lenz,2010).Theintensityandduration

ofacutesituationalanxietycanvaryamongpatientsandisestimatedtoaffect11to80%of

adultsurgicalpatientsinthepreoperativeperiod(Maranets&Kain,1999,Caumoetal,

2001).Anumberofstudiesreportthatfemalesurgicalpatientsexperiencemore

preoperativeanxietycomparedtotheirmalecounterparts(Matthias&Samarasekera,

2012,Mitchell,2012,Sears,Bolton,&Bell,2013,Yilmaz,Sezer,Gurler,&Bekar,2012).

Furthermore,femalebreastsurgerypatientsareatanincreasedriskforanxiety

attributabletoasurgicalprocedurethathasaknownorthepotentialforadiagnosisof

breastcancer(Binns-Turner,Wilson,Pryor,Boyd,&Prickett,2011,Caumoetal,2001).

AsaCertifiedRegisteredNurseAnesthetistcaringforthispatientpopulation,I

traditionallyuseanxiolyticssuchasmidazolamforanxiety,whichhasbeenshownto

producenegativephysiologicaleffects(Binns-Turneretal,2011).Thus,Ifoundmyself

searchingforamoreholisticandpatient-centeredapproachtoperioperativeanxiety.The

InstituteofMedicine(2010)definespatient-centeredcareasanassessmentofnegative

bio-behavioralchangesassociatedwithstressandtheimplementationofstrategiesto

alleviatethosechanges.Complementarytherapiessuchasmusic,acupuncture,

acupressure,relaxationtechniques,andaromatherapyarenon-pharmacological

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interventionsthatareusedfortherapeuticpurposesandhavebeenshowntoreduce

and/oralleviateanxietywithoutsequelae(Acaretal,2013,Binns-Turneretal,2011,Niet

al,2013).

Afterbeingintroducedtoanewandinnovativearomatherapyproductfrom

Bioesse®Technologies,Inc.(2013),aromatherapybecamethefocusofthisdissertation

research.Aromatherapyusesnatural,plantessences(e.g.lavender,spearmint,peppermint,

citrus)fortherapeuticpurposes(Stea,Beraudi,&DePasquale,2014;Perry,Terry,Watson,

&Ernst,2012).Througholfactoryscentinhalation,theseessentialoilsmayprovideamore

gentletreatmentoptionwithsignificantpsychologicalandphysiologicalbenefits(Bioesse®

Technologies,LLC,2013;Perryetal.,2012).Theadditionofcomplementarytherapies,

suchasaromatherapy,intheperioperativeperiodisabuddingareaofresearch.

GapsinKnowledge

Althoughstudiesoverthelastdecadehavedemonstratedthataromatherapy

positivelyaffectssurgicalpatientsinthepreoperativesetting,additionalresearchis

neededtoprovidefurtherinsightintosuccessfulmethodsofparticipantrecruitment,

anxietymeasurement,andinterventiondeliverymodalities.Inareviewoftheliteratureof

aromatherapystudiesthattargetedpreoperativepatients,thesurgicalpatientpopulation

andrecruitmentmethodsvariedamongthethreestudies(Braden,Reichow,&Halm,2009,

Fayazi,Babashahi,&Rezaei,2011,Nietal,2013)includedinthereview.Theinstruments

usedtomeasureanxietyalsovariedamongthesestudies(Braden,Reichow,&Halm,2009,

Fayazi,Babashahi,&Rezaei,2011,Nietal,2013).Forexample,theinstrumentsincludeda

visualanalogscale(VAS),thatusesasingleratingonanumericalscaleandtheState-Trait

AnxietyIndex(STAI),whichisa40-itemquestionnairethatprovidesasummativescore

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(Braden,Reichow,&Halm,2009,Fayazi,Babashahi,&Rezaei,2011,Nietal,2013).Inthese

studies,variousphysiologicalindicatorsofanxietysuchasheartrateandbloodpressure

wereusedtomeasureanxiety(Braden,Reichow,&Halm,2009,Fayazi,Babashahi,&

Rezaei,2011,Nietal,2013).Theinterventiondeliverymodalitiesdifferedamongallthree

studiesrangingfromtopicalapplicationoftheessentialoillavandintoinhalationwitha

handkerchiefcontaininglavandulatothearomaticdiffusionofbergamotoilusingan

ultrasonicaromadiffuserdevice(Braden,Reichow,&Halm,2009,Fayazi,Babashahi,&

Rezaei,2011,Nietal,2013).Theplethoraofmeasurementmodels,interventiondelivery

approachesandoutcomesdemonstrateseveralmethodologicalgaps.However,thepositive

findingservesasevidencethataromatherapyholdspromiseforanxietyreductioninthe

preoperativeperiod.Thusfurtherresearchisneededtoaddtothebodyofknowledgein

thefieldofsymptomsciencerelatedtoaromatherapy.

ExplorationoftheConceptofAnxiety

First,aprinciple-basedconceptanalysisasdescribedbyPenrodandHupcey(2005)

wasperformedtoanalyzeandclarifytheconceptofrelieffromanxietyusing

complementarytherapiesintheperioperativeperiod.Theconceptwasexploredthrough

thetenetsofaprinciple-basedanalysistodescribethematurityandboundariesofthe

epistemological,pragmatic,linguisticandlogicalprinciplestoadvancetheconcept

accordingtothecurrentstateofthescience.Theobjectiveofthisanalysiswastoexplore

relieffromanxietyforpatientsthroughcomplementarytherapy.Theoveralloutcome

addedtoabetterunderstandingofanxietywiththegoalofenhancingnursingcareinthe

perioperativeperiod.

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Second,afocusedintegrativereviewwasconductedoninstrumentsthathavebeen

usedtomeasureacutesituationalanxietyforadultsurgicalpatientsinthepreoperative

periodofhospitalization.Thestressresponsetheoryguidedthisreviewoffivemanuscripts

thatreportedtheuseofinstrumentstodetermineacutesituationalanxietyinthe

preoperativeperiodofhospitalization.Theobjectivewastosynthesizeanddescribethe

instrumentsusedtomeasurepreoperativeanxietyanddiscusstheirpsychometric

properties(Jaruzel&Gregoski,ND).

Third,afeasibilitystudywasconductedtoevaluateseveralprocessessuchas

recruitmentandimplementationofprovidingalavenderaromatherapythrougha

sustained-releasepatchappliedtothechestusingtheReach,Effectiveness,Adoption,

Implementation,andMaintenance(RE-AIM)framework(Glasgow,Vogt,&Boles,1999).

ThemeasurementmodelincludedtheuseofaVAStomeasureanxietylevelsduringthe

preoperativeperiod;thetargetpopulationwasfemalepatientsscheduleforbreastsurgery.

TheGeneralAdaptationSyndromeTheoryofStresswastheunderlyingtheoretical

frameworkforthestudy(Melnyk,&Morrison-Beedy,2012,Rice,2012).Theaimsofthis

studywereto:1)evaluateanddeterminethefeasibilityofusinganaromatherapypatchin

thepreoperativeperiodofsurgeryforanxietyusingtheRE-AIMframeworkbyassessing

recruitment,retention,adherence,andadoption,and2)collectdataonpreliminarysignals

ofefficacyonanxietymeasuredwithaVASandphysiologicalsignsofanxietyincluding

heartrateandmeanarterialbloodpressure.

TheoreticalFrameworks

TheStressResponseTheorywasusedasaguidetodefineacutesituationalanxiety

inthepreoperativeperiodofhospitalizationandformedthebasisofthetheoretical

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approachwithintheintegrativereview.TheStressResponseTheorypostulatesthe

breakdownofacutesituationalanxietyas:thethreat(i.e.,stress);theindividualreaction

(i.e.,fear,anxiety,elation);andphysiologicalfightorflightresponseofhealthandsurvival

thatincludesthecentralnervoussystemandhormonalresponses(Rice,2000,Rice,2012,

Jaruzel&Gregoski,ND).Thetheoreticaldefinitionofacutesituationalanxiety,guidedby

theStressResponseTheoryis,asubjectivefearfulfeelingofemotioninfluencedbyan

immediatesituationwhichisvariableinintensityanddurationamongpatientsinthe

preoperativeperiodofhospitalization(Acaretal,2013,Maranets&Kain,1999,Merriam-

Webster.com,2015,Rice,2000,Rice2012,Waltz,Strickland,&Lenz,2010,Jaruzel&

Gregoski,ND).

Seyle’sGeneralAdaptationSyndromeTheoryofStresswasusedastheunderlying

theoreticalframeworktodetermineifanaromatherapyinterventionwasafeasibleoption

toassistwithadaptivecopingforpreoperativeanxietyamongfemalepatientsscheduled

forbreastsurgery.Seyle’smodeldescribesathree-stageresponsetoastressor:alarmwith

activationofthesympatheticnervoussystemleadingtophysiologicalchanges;resistance

withactivationoftheparasympatheticnervoussysteminanattempttorestore

homeostaticbalance;and,exhaustionwithsusceptibilitytodiseaseanddeathif

homeostaticbalancecouldnotberestored(Rice,2012).ThegoaloftheGeneralAdaptation

SyndromeTheoryofStressisadaptivecopinginresponsetothestressor(i.e.surgery,

diagnosis,fear,etc.)tobalancethebiological,physiologicalandsocialprocessestoresolve

thestressresponse(Rice,2012).

DescriptionofManuscriptsI,II,andIII

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Presentedinthisdissertationarethreemanuscriptsrelatedtoacutesituational

anxietyintheperioperativeperiodandcomplementarytherapiesthatshowcasethe

trajectoryofmyresearch.Thefirstmanuscriptisananalysisandclarificationofthe

conceptofrelieffromanxietyusingcomplementarytherapiesintheperioperativeperiod.

Thesecondpublishedmanuscriptisasynthesisanddescriptionoftheinstrumentsused

overthelastdecadetomeasurepreoperativeanxiety.Thefinalmanuscriptisareportofa

feasibilitystudyconductedonaromatherapyforpreoperativeanxietyamongfemalebreast

surgerypatients.

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References

Acar,H.V.,Cuvaş,Ö.,Ceyhan,A.,&Dikmen,B.(2013).Acupunctureonyintangpointdecreasespreoperativeanxiety.JournalofAlternative&ComplementaryMedicine,19(5),420-424.doi:10.1089/acm.2012.0494

Binns-Turner,P.G.,Wilson,L.L.,Pryor,E.R.,Boyd,G.L.,&Prickett,C.A.(2011).Perioperativemusicanditseffectsonanxiety,hemodynamics,andpaininwomenundergoingmastectomy.AANAJournal,79(4Suppl),S21-27.

BioesseTechnologies,Inc.(2013).BenefitsofBioesse®patch.Retrievedfromhttp://bioessetech.com/benefits

Braden,R.,Reichow,S.,&Halm,M.A.(2009).Theuseoftheessentialoillavandintoreducepreoperativeanxietyinsurgicalpatients.JournalofPeriAnesthesiaNursing,24(6),348-355.doi:10.1016/j.jopan.2009.10.002

Caumo,W.,Schmidt,A.P.,Schneider,C.N.,Bergmann,J.,Iwamoto,C.W.,Adamatti,L.C.,Bandeira,D.,&Ferreira,M.B.(2001).Riskfactorsforpostoperativeanxietyinadults.Anaesthesia,56(8),720-8.PubMedPMID:11493233.

Fayazi,S.,Babashahi,M.,Rezaei,M.(2011).Theeffectsofinhalationaromatherapyonanxietylevelofthepatientsinpreoperativeperiod.IranianJournalofNursingandMidwiferyResearch,16(4),278-283.

Glasgow,R.E.,Vogt,T.M.,&Boles,S.M.(1999).Evaluatingthepublichealthimpactofhealthpromotioninterventions:TheRE-AIMframework.AmericanJournalofPublicHealth,89(9),1322-1327.

InstituteofMedicine(2001).HealthandBehavior:Theinterplayofbiological,behavioral,andsocietalinfluences.Washington,DC:NationalAcademyPress.Retrievedfromhttp://books.nap.edu/openbook.php?record_id=9838&page=R3

Jaruzel,C.B.,&Gregoski,M.J.(NoDate).Instumentstomeasurepreoperativeacutesituationalanxiety:Anintegrativereview.AANAJournal.

Maranets,I.,&Kain,Z.N.(1999).Preoperativeanxietyandintraoperativeanestheticrequirements.AnesthesiaandAnalgesia,89(6),1346-51.

Matthias,A.T.,&Samarasekera,D.N.(2012).Preoperativeanxietyinsurgicalpatients-experienceofasingleunit.ActaAnaesthesiolTaiwan,50(1),3-6.doi:10.1016/j.aat.2012.02.004.

Melnyk,B.M.,&Morrison-Beedy,D.(2012).Interventionresearch:Designing,conducting,analyzing,andfunding.NewYork,NY:SpringerPublishingCompany.

Merriam-Webster.(2015).Acute,Situational,&Anxiety.Retrievedfromhttp://www.merriam-webster.com,2015.

Mitchell,M.(2012).Influenceofgenderandanaesthesiatypeondaysurgeryanxiety.JournalofAdvancedNursing,68(5),1014-1025.doi:10.1111/j.1365-2648.2011.05801.x

Ni,C.H.,Hou,W.H.,Kao,C.C.,Chang,M.L.,Yu,L.F.,Wu,C.C.,&Chen,C.(2013).Theanxiolyticeffectofaromatherapyonpatientsawaitingambulatorysurgery:Arandomizedcontrolledtrial.EvidenceBasedComplementaryandAlternativeMedicine.doi:10.1155/2013/927419

Penrod,J.,&Hupcey,V.(2005).Enhancingmethodologicalclarity:Principle-basedconceptanalysis.JournalofAdvancedNursing,50(4),403-409.doi:10.1111/j.1365-2648.2005.03405.x

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Perry,R.,Terry,R.,Watson,L.K.,&Ernst,E.(2012).Islavenderananxiolyticdrug?Asystematicreviewofrandomizedclinicaltrials.Phytomedicine,19(8-9),825-835.doi:10.1016/j.phymed.2012.02.013

Sears,S.R.,Bolton,S.,Bell,K.L.(2013).Evaluationof“StepstoSurgicalSuccess”(STEPS):Aholisticperioperativemedicineprogramtomanagepainandanxietyrelatedtosurgery.HolisticNursingPractice,27(6),349-357.

Stea,S.,Beraudi,A.,&DePasquale,D.(2014).Essentialoilsforcomplementarytreatmentofsurgicalpatients:Stateoftheart.Evidence-BasedComplementaryandAlternativeMedicine,Feb24,doi:10.1155/2014/726341

Waltz,C.,Strickland,O.,&Lenz,E.(2010).Measurementinnursingandhealthresearch.4thed.NewYork,NY:SpringerPublishingCompany.

YilmazM,SezerH,GürlerH,BekarM.(2012).Predictorsofpreoperativeanxietyinsurgicalinpatients.JournalofClinicalNursing,21(7-8),956-64.doi:10.1111/j.1365-2702.2011.03799.x.

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ManuscriptI

RelieffromAnxietyUsingComplementaryTherapiesinthePerioperativePeriod:APrinciple-basedConceptAnalysis

CandaceB.Jaruzel,MSN,CRNA

PhDCandidateMedicalUniversityofSouthCarolina

CollegeofNursingCharleston,SouthCarolina

Correspondence:[email protected]

TeresaJ.Kelechi,PhD,RN,FAANProfessorandDavidandMargaretClareEndowedChair

MedicalUniversityofSouthCarolinaCollegeofNursing

Charleston,SouthCarolinaCorrespondence:[email protected]

AcceptedforpublicationinComplementaryTherapiesinClinicalPracticeinApril2016.

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RelieffromAnxietyUsingComplementaryTherapiesinthePerioperativePeriod:APrinciple-basedConceptAnalysis

Abstract

Aimsandobjectives.Toanalyzeandclarifytheconceptofprovidingrelieffromanxiety

usingcomplementarytherapiesintheperioperativeperiodutilizingtheepistemological,

pragmatic,linguisticandlogicalprinciplesofaprinciple-basedconceptanalysistoexamine

thestateofthescience.

Background.Themajorityofpatientsscheduledforsurgeryexperienceanxietyinthe

perioperativeperiod.Anxietyhasthepotentialtolimitapatient’sabilitytoparticipatein

hisorhercarethroughouttheirhospitalization.Althoughmedicationsaretheconventional

medicaltreatmentforanxietyintheperioperativeperiod,theadditionofacomplementary

therapycouldbeaneffectiveholisticapproachtoprovidingrelieffromanxiety.

Design.Principle-basedconceptanalysis.

Methods.In2015,strategicliteraturesearchesofCINHALandPUBMEDusingkeywords

wereperformed.Fifty-sixfulltextarticleswereassessedforeligibility.

Results.Twelvestudieswereusedinthefinalanalysistoclarifytheconceptofrelieffrom

anxietyusingcomplementarytherapiesintheperioperativeperiod.

Conclusion.Thisanalysishasclarifiedthematurityandboundaries,withinthefour

principlesofaprinciple-basedconceptanalysis,oftheconceptofrelieffromanxietyusing

complementarytherapiesintheperioperativeperiod.Agreaterunderstandingofrelief

fromanxietyusingcomplimentarytherapiesintheperioperativeperiodasanadjunctto

conventionalmedicinewillallowperioperativenursesandanesthesiaproviderstomodify

andspecifytheplanofcarefortheirsurgicalpatients.Theuseofcomplementarytherapies

21

forreliefintheperioperativeperiodappearstobeanareaofpromisingresearchand

treatmentforpatients,familiesandproviders.

Keywords:relief,anxiety,perioperativecare,perioperativeperiod,complementary

therapy

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Introduction

OneofthetopprioritiesofRegisteredNursesandCertifiedRegisteredNurse

Anesthetistsistopreventand/ormanageanxietyintheperioperativeperiod.

Unfortunately,thereisnoconsensusonconceptualandoperationaldefinitionsofrelief

fromanxiety,andtherearealimitednumberofdefinitivemeasuresspecifictoanxietyfor

surgicalpatientsreceivingcareintheperioperativeperiod.Thesegapsmakeitdifficultto

haveacomprehensiveunderstandingofwhatitmeanstothepatienttohaverelieffrom

anxietyandtoidentifythebestapproachestoanxietyreliefinpatientsundergoingsurgery.

Thetermreliefhasbeenusedinnumeroussettingsthroughouthistory.Reliefof

anxietyforsurgicalpatientsintheperioperativeperiodisatopicofinteresttothose

providingperioperativecare.Anxietyisdefinedas“afeelingofworry,nervousness,or

unease,typicallyaboutanimminenteventorsomethingwithanuncertainoutcome”.1To

date,nostudieshavedirectlyreportedreliefinregardtoanxietyintheperioperative

period.Insteadwordsandphrases,suchasprevention,reduction,minimization,effectsof,

anddecreasedlevels,concerninganxietyforsurgicalpatientsarethetermsusedinvarious

studiesinthepreoperativeandpostoperativesetting.

ThedefinitionofreliefinTheOxfordEnglishDictionary1is“easeoralleviationgiven

toorreceivedbyapersonthroughtheremovalorlesseningofsomecauseofdistressor

anxiety;deliverancefromwhatisburdensomeorexhaustingtothemind;mental

relaxation;easefrom,orlesseningof,physicalpainordiscomfort;anagreeablechangeof

objecttothemindoroneofthesenses.”Tabor’sCyclopedicMedicalDictionary2defines

reliefas“thealleviationorremovalofadistressingorpainfulsymptom.”Kolcaba’smid-

rangetheoryofcomfortdefinesreliefasastateofhavingaspecificdiscomfortmitigatedor

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relieved.3,4Thereby,toprovidereliefanactionmustbetakentorelieve.Relieveisdefined

as:“toraise(aperson)outofsometrouble,difficulty,ordanger;torescue,succor,aidor

assistinstraits;todeliverfromsomethingtroublesomeoroppressive;toeaseorfree(a

person,themind,etc.)fromsorrow,fear,doubt,orothersourceofmentaldiscomfort;to

give(aperson,partofthebody,etc.)easeorrelieffromphysicalpainordiscomfort;toease

ormitigate(whatispainfuloroppressive);torenderlessgrievousorburdensome”.1

Complementarytherapiescombinedwithconventionalmedicaltreatmentcould

offeraneffective,holistic,andbeneficialapproachtoproviderelieffromdistressing

symptoms,especiallyanxiety,acommondistressfulsymptomexperiencedbyupto80%of

surgicalpatientsintheperioperativeperiod.5Usingaprinciple-basedmethodofconcept

analysisasdescribedbyPenrodandHupcey6,thepurposeofthismanuscriptistoexplore

theconceptofrelieffromanxietyusingcomplementarytherapiesforsurgicalpatients

withintheperioperativeperiod.Explorationoftheconceptthroughthetenetsofa

principle-basedanalysistoclarifythematurityandboundariesoftheepistemological,

pragmatic,linguisticandlogicalprincipleswillassistintheadvancementoftheconceptof

relieffromanxietyusingcomplementarytherapyaccordingtothecurrentstateofthe

science.6Aprinciple’smaturityisdescribedbytheconcept’slevelofdevelopmentbasedon

thecurrentstateofthescience.Conceptsarematurewithinaprinciplewhentheyare

clearlydefinedanddifferentiatedfromotherconcepts(epistemological)andareapplicable

andusefulforscientificinquiry(pragmatic).6Aprinciple’sboundariesdescribeaconcept

withinacontext.Aconceptwillholditsboundariesifitisusedconsistentlyand

appropriatelywithinacontext(linguistic)orbeunabletoholditsboundarieswhenthe

conceptbecomesblurredwhenpositionedwithotherconcepts(logical).6

24

Specifically,thisconceptanalysisaimstoclarifytheconceptofrelieffromanxietyin

theperioperativeperiodusingcomplementarytherapiesasanadjuncttoconventional

medicaltreatmentforsurgicalpatients.Aclearerunderstandingoftheconceptofrelief

fromanxietywouldallowanesthesiaandperioperativeproviderstomodifytheplanof

careforsurgicalpatientsexperiencinganxiety.Theobjectiveistoaddabetter

understandingofrelieffromanxietyforpatientsthroughtheuseofcomplementary

therapiestoenhancenursingcareintheperioperativeperiod.

Methods

SearchQuestions

Thequestionsthatguidedthereviewoftheliteraturetoaddresstheconceptof

relieffromanxietyintheperioperativeperiodusingaprinciple-basedconceptanalysisare

asfollows:Howwouldclarifyingtheconceptofrelieffromanxietyusingcomplementary

therapiesintheperioperativeperiodchangehealthcareforboththepatientandthe

provider?Insurgicalpatients,hastheadditionofcomplementarytherapiesinthe

perioperativeperiodcomparedtoconventionalmedicaltreatmentaloneledtoreliefof

anxietyorbetteroutcomes?Whathavepreviousresearchersusedtodefineandmeasure

relief?Whatcomplementarytherapiestodatehavebeeninvestigatedtorelieveanxietyin

theperioperativeperiod?

DataSources

TheCumulativeIndexofNursingandAlliedHealthLiterature(CINAHL)and

PUBMEDdatabasesweresearched.SearchtermsusedinCINAHLwereanxiety,

perioperativecareandalternativetherapies.Eachtermwas“exploded”toincludeallmajor

subheadings.TheMeSHdatabaseforPUBMEDwassearchedusinganxiety[MeSH],

25

perioperativeperiod[MeSH],andcomplimentarytherapies[MeSH].PUBMEDClinical

Querieswasalsosearchedusingthetermsanxiety,complimentarytherapies,and

preoperativecare.Inclusioncriteriaforeachdatabase/searchengineincluded:scholarly

journals,researchstudies,andpublicationwithinthelast15years.Exclusioncriteriafor

eachdatabase/searchenginethatledtothefinalsampleincludedAdult(19–44years)and

Englishlanguage.Afinalresultof56scholarlyjournalarticleswereretrievedforreview.

Twelvestudiesutilizingcomplementarytherapiesintheperioperativeperiodforanxiety

andpublishedwithinthelast15yearswereselectedforinclusiontoreviewforthis

analysis(Figure1).

Method

Themostrecentresearchonanxietyreliefwithcomplementarytherapiesinthe

perioperativeperiodwasanalyzedusingaprinciple-basedconceptanalysis.6Findingsof

the12studies(7randomizedcontroltrials,1quasi-experimental,1prospective

experimentalpretest/posttest,1groupassignmentstudy,1experimental3-groupdesign,

and1questionnaire)werecategorizedbyeachprinciple(Table1.Epistemological,

Pragmatic,Linguistic,andLogical)astheycontributetotheunderstandingofthestrengths

andlimitationsoftheconcept.

Results

EpistemologicalPrinciple

Theepistemologicalprinciplefocusesonacleardefinitionanddifferentiationofa

concept.6Relieffromanxietywasdescribedandmeasuredbytheresearchersineachstudy

reviewed(Table1).Descriptionsofreliefincludedwordssuchasdecline,decreased,

lowered,reducedandreduction.Noconclusivedefinitionofrelieffromanxietyusing

26

complementarytherapiesintheperioperativeperiodwasdefined.Ineachofthe12studies

analyzed,relieffromanxietyusingcomplementarytherapiesintheperioperativeperiod

wasnotspecificallydifferentiatedfromotherconceptssuchaspain,BispectralIndex(BIS)

technologytomonitorlevelofanesthesia,andvitalsignchanges(i.e.heartrate,blood

pressure,meanarterialpressure,respiratoryrate).Measurementinstrumentsincluded

StateTraitAnxietyIndex(STAI),StateAnxietyIndex(SAI),VisualAnalogScales(VAS),

AmsterdamPreoperativeAnxietyandInformationScale(APAIS),urineepinephrinelevels,

andBIS(Table1).

PragmaticPrinciple

Thepragmaticprinciplefocusesontheapplicabilityandusefulnesswithinthe

scientificrealmofinquiry.6Eachstudyrevieweddescribedtheapplicabilityandusefulness

ofanxietyreliefusingcomplementarytherapieswithintheperioperativeperiod.Inthe

perioperativeperiod,Mitchell7foundthatwhilethemajorityofpatientsexperience

anxiety,itismoreprevalentinfemalepatientsandthoseundergoinggeneralanesthesia.

Anumberofcomplementarytherapiesareusedintheperioperativesettingthat

rangefromminimallyinvasiveacupuncturetononinvasivemusicorguidedimagery.

Findingfromtwostudiessuggestedthattheuseofacupressurepointsinthepreoperative

settingwasstatisticallysignificantindecreasinganxietyandBIS(p<0.001)8andreducing

anxietylevels(p<0.001)9.Acar,Cuvas,Ceyhan,andDikmen10foundthatacupunctureat

theyintangpointwasstatisticallysignificantinreducingpreoperativeanxiety(p=0.018)

andBispectralindexlevels(p<0.0004).Theuseoftheessentialoil,lavandin,for

therapeuticsensationwasalsofoundtobestatisticallysignificantinloweringpreoperative

anxiety(p=0.01)atthetimeoftransfertotheOperatingRoom.11Inaddition,Gonzaleset

27

al.12foundthatguidedimageryperformedpreoperativelyresultedinstatistically

significant(p=0.002)decreasesinanxietylevelsinthepostoperativeperiod.

Furthermore,findingsfromthreeadditionalstudiessuggestedthatmusiclowered

anxietylevels(p<0.001)throughouttheperioperativeperiod.13-15BrungesandAvigne16

didnotreportstatisticalsignificancebutreportedfindingssuggestingthatmusictherapy

resultedinlowerepinephrinehormonelevels,theneuroendocrineresponsetostress,in

theperioperativeperiod.Additionally,Johnson,Raymond,andGoss17didnotreport

statisticalsignificancebutreportedfindingsthatsuggestedperioperativemusicandnoise-

blockingheadsetsbothresultedindecreasedanxietyscoresintheperioperativeperiod.

Seers,Chrichton,Tutton,Smith,andSaunders18studiedrelaxationtechniquesand

foundtherewerenostatisticallysignificant(p=0.20)decreasesinanxietyfrompre-

interventiontoimmediatelypostinterventionand1,2,3,and4hourslater.Anxietywas

measuredwiththeState-TraitAnxietyIndex(STAI).Althoughthefindingswerenot

statisticallysignificant,theinvestigatorsreporteddecreasedlevelsofanxietyinthe

surgicalpatientpopulation.

LinguisticPrinciple

Thelinguisticprincipleevaluatestheappropriateuseoftheconceptincontext.6The

initialliteraturereviewusingthekeywords,relief,anxiety,perioperativecare,perioperative

period,andcomplementarytherapyinCINAHLandPUBMEDyielded143studies.Theterms

reduced,lowered,declineanddecreasedareconsistentlyusedinhealthcareandresearch

contextsinregardstorelieffromanxiety.Acaretal.10,Cookeetal.14,andValieeetal.9

reportedreducedanxietywithacomplementarytherapy.Agarwaletal.8,Gonzalesetal.12,

Johnsonetal.17,andSeersetal.18reporteddecreasedanxietyfollowingacomplementary

28

therapy.Binns-Turner,etal.13foundaperioperativedeclineinanxietywithamusic

interventionandbothanessentialoil11andmusic15interventionloweredpreoperative

anxiety.

LogicalPrinciple

Thelogicalprinciplereferstotheintegrationoftheconceptwithrelatedconcepts.6

Iftheconceptbecomesblurredwhenpositionedwithotherconcepts,thentheconceptis

unabletoholditsboundarieswithinthelogicalprinciple.6All12studiesaimedtoassess

relieffromanxietyusingcomplementarytherapies;however,theyalsodescribedand

measuredotherconceptssuchaspainandpainscorechanges9-13,18,vitalsignsandvital

signchanges9,13,15,lengthofstay12,16andBispectralindex(BIS)measurements8,10.

Thereislimitedresearchonreliefofanxietyusingcomplementarytherapiesinthe

perioperativeperiod.However,fromthedatageneratedwithintheframeworkofthis

analysis,complementarytherapieshaveprovidedrelieffromanxietyforsurgicalpatients

intheperioperativeperiod.Reductionsinanxietyindices,vitalsignmeasurements,pain

scores,lengthofhospitalization,andBISindexvaluesareindicativeofrelief.

Discussion

Reliefisadynamicconcept,andeachresearcherhasdescribedandmeasuredrelief

ofanxietyutilizingcomplementarytherapiesdifferently.Forthisanalysis,reliefwas

definedasthereduction,decrease,orloweringofanxietythroughtheuseofa

complementarytherapyintheperioperativeperiod.Thisdefinitionofreliefisnot

epistemologicallymaturebutdoesprovideclaritytotheconceptofrelieffromanxiety

usingcomplementarytherapiesforperioperativeproviders.

29

Theconceptofrelieffromanxietyusingcomplementarytherapyinthe

perioperativeperiodisshowntobebothpragmaticallyandlinguisticallymature.

Pragmaticmaturitywasshownbyeachstudydescribingtheapplicabilityandusefulnessof

anxietyreliefusingcomplementarytherapiessuchasacupressure,acupuncture,essential

oils,guidedimagery,andmusicwithintheperioperativeperiod.Additionally,eachstudy

ledtoabetterunderstandingoftheapplicabilityandusefulnessofthecurrent

complementarytherapiesbeingusedintheperioperativeperiod,whichmay,inturn,

enhancehealthcareforbothpatientsandproviders.Linguisticmaturitywasshownbythe

appropriateuseofthetermsreduced,lowered,declineanddecreasedinthecurrentbodyof

researchtodescriberelieffromanxietyusingcomplementarytherapiesinthe

perioperativeperiod.Theuseofthesetermstodescriberelieffromanxietyinpatients

receivingacomplementarytherapyintheperioperativeperioddemonstratestheconcept’s

abilitytoholditslinguisticboundaries.

Theconceptofrelieffromanxietyusingcomplementarytherapiesinthe

perioperativeperiodisunabletoholditsboundarieswhenpositionedwithotherconcepts

withinthelogicalprinciple.6Theconceptofrelieffromanxietyusingcomplementary

therapiesbecomesblurredwhenotherconceptssuchaspain,vitalsignchanges,andBIS

monitoringareconsidered.6Furtherresearchisneededtoestablishlogicalboundariesfor

thisconcept.

Researchisalsoneededtoaddressgapsidentifiedintheliterature.Thecurrent

literaturerevealednopreviousconceptanalysisorconceptualdefinitionofrelieffrom

anxietyusingcomplementarytherapiesintheperioperativeperiod.Likewise,research

aimedatanxietyreliefintheperioperativeperiodwithcomplementarytherapieshasbeen

30

sparseinthelast15yearsandbeyond.Additionally,numerouscomplementarytherapies

(i.e.yoga,deepbreathingexercises,meditation,etc.)havenotbeenstudiedaswaysto

providerelieffromanxietyforsurgicalpatientsintheperioperativeperiod.

Thisanalysisindicatesthatanesthesia,medicine,nursing,psychology,andsocietyas

awholearebeginningtoembracecomplementarytherapiestorelieveanxietyandmore.

Thisanalysisalsodemonstrateshowcomplementarytherapieshaveprovided“relief”from

anxietyforsurgicalpatientsandhowtheyarebecomingmorepopularintheperioperative

settings.Furtherresearchoncomplementarytherapiesaimedatrelievinganxietyis

needed,particularlymethodsinwhichtherapiescanbebestintegratedintopracticeinthe


Limitations

Generalizabilityoffindingsfromthereviewislimitedasonlyresearchregarding

anxietyintheperioperativesettingwasreviewed.Despitethescientificrigorofaprinciple-

basedconceptanalysisof12studies,thelimitednumberofpublishedstudiesoverthelast

15years,theuseofonlytwodatabasesearchesandEnglishlanguageonlycouldpotentially

limitthefindingsofthisanalysis.

Conclusion

Theconceptofrelieffromanxietyiscriticalinhealthcare.Careguidedbyawell-

definedconceptofrelieffromanxietyusingcomplementarytherapiesintheperioperative

period,whichprovidestheabilitytoassessanxietyasauniqueentity,isappropriateforall

surgicalpatients.AccordingtotheAgencyforHealthcareResearchandQuality19,millions

ofsurgeriesareperformedannuallyintheUnitedStates.Theconceptofreliefasanaction

takentoease,alleviateorremovethesymptomsofdistress,discomfort,painand/or

31

anxietyduringtheperioperativeperiodforsurgicalpatientsisanimportantconceptfor

providersinmultiplecontexts.Thisanalysisilluminatedthatrelieffromanxietyusing

complementarytherapiesalongwithconventionalmedicaltreatmentcanbeeffectivein

theperioperativeperiodandproducessubstantialbenefitsforsurgicalpatients.Further

researchtodefineandmeasurerelieffromanxietyusingdifferentcomplementary

therapiesisnecessary.Theuseofcomplementarytherapiesforreliefofanxietyappearsto

beanareaofpromisingtreatmentforpatients,families,andprovidersintheperioperative

period.

32

References

1.TheOxfordEnglishDictionary.InJ.A.Simpson&E.S.C.Weiner(Eds.).TheOxfordEnglishDictionary(2ed.).Oxford:ClarendonPress;1989.

2.Taber'scyclopedicmedicaldictionary.InC.L.Thomas(Ed.).Taber’scyclopedicmedicaldictionary(18ed.).Philadelphia:F.A.DavisCompany;1997

3.Kolcaba,K.,&DiMarco,M.A.Comforttheoryanditsapplicationtopediatricnursing.PediatricNursing.2005;31(3):187-194

4.Wilson,L.,&Kolcaba,K.Practicalapplicationofcomforttheoryintheperianesthesiasetting.JournalofPeriAnesthesiaNursing.2004;19(3):164-173.doi:10.1016/j.jopan.2004.03.006

5.Maranets,I.,&Kain,Z.N.Preoperativeanxietyandintraoperativeanestheticrequirements.AnesthesiaandAnalgesia,1999;89(6):1346-51.

6.Penrod,J.,&Hupcey,V.Enhancingmethodologicalclarity:Principle-basedconceptanalysis.JournalofAdvancedNursing,2005;50(4);403-409.doi:10.1111/j.1365-2648.2005.03405.x

7.Mitchell,M.Influenceofgenderandanaesthesiatypeondaysurgeryanxiety.JournalofAdvancedNursing,2012;68(5):1014-1025.doi:10.1111/j.1365-2648.2011.05801.x

8.Agarwal,A.,Ranjan,R.,Dhiraaj,S.,Lakra,A.,Kumar,M.,&Singh,U.Acupressureforpreventionofpre-operativeanxiety:Aprospective,randomised,placebocontrolledstudy.Anaesthesia,2005;60(10):978-981.doi:10.1111/j.1365-2044.2005.04332.x

9.Valiee,S.,Bassampour,S.S.,Nasrabadi,A.N.,Pouresmaeil,Z.,&Mehran,A.Effectofacupressureonpreoperativeanxiety:Aclinicaltrial.JournalofPeriAnesthesiaNursing,2012;27(4):259-266.doi:10.1016/j.jopan.2012.05.003

10.Acar,H.V.,Cuvaş,Ö.,Ceyhan,A.,&Dikmen,B.Acupunctureonyintangpointdecreasespreoperativeanxiety.JournalofAlternative&ComplementaryMedicine,2013;19(5):420-424.doi:10.1089/acm.2012.0494

11.Braden,R.,Reichow,S.,&Halm,M.A.Theuseoftheessentialoillavandintoreducepreoperativeanxietyinsurgicalpatients.JournalofPeriAnesthesiaNursing,2009;24(6):348-355.doi:10.1016/j.jopan.2009.10.002

12.Gonzales,E.A.,Ledesma,R.J.A.,McAllister,D.J.,Perry,S.M.,Dyer,C.A.,&Maye,J.P.Effectsofguidedimageryonpostoperativeoutcomesinpatientsundergoingsame-daysurgicalprocedures:Arandomized,single-blindstudy.AANAJournal,2010;78(3):181-188.

13.Binns-Turner,P.G.,Wilson,L.L.,Pryor,E.R.,Boyd,G.L.,&Prickett,C.A.Perioperativemusicanditseffectsonanxiety,hemodynamics,andpaininwomenundergoingmastectomy.AANAJournal,2011;79(4Suppl):S21-27.

14.Cooke,M.,Chaboyer,W.,Schluter,P.,&Hiratos,M.Theeffectofmusiconpreoperativeanxietyindaysurgery.JournalofAdvancedNursing,2005;52(1):47-55.doi:10.1111/j.1365-2648.2005.03563.x

15.Ni,C.-H.,Tsai,W.-H.,Lee,L.-M.,Kao,C.-C.,&Chen,Y.-C.Minimisingpreoperativeanxietywithmusicfordaysurgerypatients-arandomisedclinicaltrial.JournalofClinicalNursing,2012;21(5/6):620-625.doi:10.1111/j.1365-2702.2010.03466.x

16.Brunges,M.,&Avigne,G.Clinicalinnovations.Musictherapyforreducingsurgicalanxiety.AORNJournal,2003;78(5):816-818.doi:10.1016/S0001-2092(06)60641-8

33

17.Johnson,B.,Raymond,S.,&Goss,J.Perioperativemusicorheadsetstodecreaseanxiety.JournalofPeriAnesthesiaNursing,2012;27(3):146-154.doi:10.1016/j.jopan.2012.03.001

18.Seers,K.,Crichton,N.,Tutton,L.,Smith,L.,&Saunders,T.Effectivenessofrelaxationforpostoperativepainandanxiety:Randomizedcontrolledtrial.JournalofAdvancedNursing,2008;62(6):681-688.doi:10.1111/j.1365-2648.2008.04642.x

19.AgencyforHealthcareResearchandQuality.(2013).Surgery.MedlinePlus.Accessedfromwww.nlm.nih.gov/medlineplus/surgery.html

34

Figure1.Datasourcesflowchart

Initialresultsofdatabasesearch:

• CINHAL(N=126)• PUBMED(N=17)

PotentiallyeligiblestudyreportsFull-textarticlesassessedforeligibility(N=56)

Limits/filters:• English• Adult(19–

44years)

Full-textarticles(N=12)

ExcludedDidnotmeetinclusion

criteria(N=34)

Table1.Principle-basedconceptanalysis

Author(s),Year,StudyDesign,SampleSize

(n) Epistemiological Pragmatic Linguistic LogicalAcar,Cuvas,Ceyhan,&Dikmen,2013RandomizedControlTrial(RCT)n=52

AcupuncturetoreduceanxietyMeasurementInstruments:State-TraitAnxietyInventoryBIS

Yintangpointacupuncturereducedpreoperativeanxiety(p=0.018)andBISvalues(p<0.0004)

Reducedanxietypre-operatively

Preoperativesetting

• Anxiety• BIS

Agarwaletal.,2005RCTn=76

AcupressuretodecreaseanxietyMeasurementInstruments:VisualStressScaleBIS

Extra1pointacupressuredecreasedanxietyandBISpre-operatively(p<0.001)

Decreasedanxietypreoperatively

Preoperativesetting

• Anxiety• BIS

Binns-Turner,Wilson,Pryor,Boyd,&Prickett,2011Quasi-experimentaln=30

MusictodeclineanxietylevelsMeasurementInstrument:StateAnxietyScale

Perioperativemusicrevealedasignificantdeclineinanxietylevels(p<0.001)

Perioperativedeclineinanxiety

Perioperativeperiod-preoperative,intraoperative,andpostoperative

• Anxiety• Vitalsigns• Pain

Braden,Reichow,&Halm,2009Prospectiveexperimentalpretest/post-testn=150

EssentialoilforloweredanxietyMeasurementInstrument:VisualAnalogscales

Essentialoil,Lavandin,loweredanxietyonORtransferpreoperatively(p=0.01)

Loweredanxietypreoperatively

Preoperativesetting

• Anxiety• Pain

Brunges&Avigne,2003Groupassignmentstudyn=44

MusictolowerEpinephrinelevelsMeasurementInstrument:Urineepinephrinelevel

MusictherapyresultedinlowerEpinephrinelevelsandshorterlengthsofstay

Lowerepinephrine(therebyanxiety)levelsIntheperioperativeperiodthroughhospitaldischarge

Perioperativeperiodthroughdischargefromhospital.

• Epinephrinelevels

• Anxiety• Lengthof

hospitalstay

36

Cooke,Chaboyer,Schluter,&Hiratos,2005RCTn=180

MusictoreducemeananxietyscoresMeasurementInstrument:State-TraitAnxietyInventory

Preoperativemusicreducedmeananxietyscores(p<0.001)


Preoperativesetting

• Anxiety

Gonzalesetal.,2010RCTn=44

GuidedimagerytodecreaseanxietylevelsMeasurementInstruments:AmsterdamPreoperativeAnxiety&InformationScaleVisualAnalogScale

Preoperativeguidedimageryresultedindecreasedanxietylevelspostoperatively(p=0.002)

Decreasedanxietypreoperativelyandpostoperatively

Preoperativeandpostoperativesetting

• Anxiety• Pain• Lengthof

stayinPACU

Johnson,Raymond,&Goss,2012Experimentalthree-groupdesignwithpre-andpost-measurementofanxietyn=119

MusicandheadsetstodecreaseanxietyscoresMeasurementInstrument:RapidAssessmentAnxietytool

Perioperativemusicandnoise-blockingheadsetsbothresultedindecreasedanxietyscores

Decreasedanxietyintheperioperativeperiod

Perioperativeperiod-preoperative,intraoperative,andpostoperative

• Anxiety

Mitchell,2011Questionnairen=674

MeasurementInstrument:Questionnaire

Anxietyisexperiencedbythemajoritybutwasfoundtobemoreprevalentwithgeneralanesthesiaandfemalepatients

Surgery

Ni,Tsai,Lee,Kao,&Chen,2012RCTn=183

MusictoloweranxietyMeasurementInstrument:State-TraitAnxietyInventory

Musicalinterventionpreoperativelyloweredanxiety(p<0.001)

Loweredanxietypreoperatively

Preoperativesetting

• Anxiety• Vitalsigns

37

Seers,Chrichton,Tutton,Smith,&Saunders,2008RCTn=118

RelaxationtechniquestodecreaseanxietyMeasurementInstrument:State-TraitAnxietyInventory

Relaxationtechniquesdecreasedanxiety(p=0.20)

Decreasedanxietyfrompre-interventiontoimmediatelypost-interventionand1,2,3,and4hourslater

Pre-admissionclinic,pre-intervention,immediatelypost-interventionand1,2,3and4hourslater.

• Anxiety• Pain

Valiee,Bassampour,Nasrabadi,Pouresmaeil,&Mehran,2012RCTn=70

AcupressuretoreduceanxietylevelsMeasurementInstrument:VisualAnalogScale

Acupressurereducedanxietylevelspreoperatively(p<0.001)


Preoperativesetting

• Anxiety• Vitalsigns

38

ManuscriptII

Instrumentstomeasurepreoperativeacutesituationalanxiety:Anintegrativereview

CandaceB.Jaruzel,MSN,CRNAAssistantProgramDirector

MedicalUniversityofSouthCarolinaAnesthesiaforNursesDivisionCharleston,SouthCarolina

Correspondence:[email protected]

MathewJ.Gregoski,PhD,MSAssistantProfessor

MedicalUniversityofSouthCarolinaCollegeofNursingandDepartmentofPublicHealth

Charleston,SouthCarolinaCorrespondence:[email protected]

AcceptedforpublicationintheAANAJournalinSeptember2015

39

Instrumentstomeasurepreoperativeacutesituationalanxiety:Anintegrativereview

Abstract

Acutesituationalanxietyisasubjectivefearfulfeelingofemotionthatisinfluencedbyan

immediatesituationandcanvaryinintensityanddurationamongpatientsinthe

preoperativeperiodofhospitalization1-4.Inadults,theincidenceofpreoperativeacute

situationalanxietyrangesfrom11%to80%2,5.Untreatedanxietyintheperioperative

periodcanleadtomultipledeleteriouseffectsforpatients.Previousreviewson

instrumentstomeasureanxietyhavenotfocusedonthepreoperativeperiodof

hospitalizationforsurgicalpatients.Theobjectiveofthisintegrativereviewistosynthesize

anddescribetheinstrumentsusedoverthelastdecadetomeasurepreoperativeanxietyin

thesurgicalsetting.Methods:AsystematicsearchstrategyofthePubMed,Cumulative

IndextoNursingandAlliedHealthLiterature(CINAHL),andPsycINFOdatabaseswasused

toreviewtheliterature.Results:Atotalof370manuscriptswereidentifiedbutonly5met

theinclusioncriteriaforthisreview.Withinthe5manuscripts,varyinglevelsofreliability,

validity,andfeasibility,oftheinstrumentswereinconsistentlyreportedaswellascontext

considerations.Conclusions:Reliabilityandvalidityarenotconsistentlyreportedamong

preoperationalanxietymeasurementinstrumentsmakingitdifficultforprovidersto

measurepreoperationalanxietyandprovidetreatmentbasedontheinstrumentresults.

Keywords:Anxiety;anxietyindex;preoperativeperiod;complementarytherapy;

instrument.

Introduction

Acutesituationalanxietyisasubjectivefeelingofanunpleasant,fearfulemotionor

uneasinessthatisinfluencedbytheimmediatesituation1-4.Theintensityanddurationof

40

acutesituationalanxietycanvarywidelyamongbothpatientsandenvironmentalsettings,

thisisespeciallynoticeableinthehospitalenvironmentsduringthepreoperativeperiod2.

Theestimatedthattheincidenceofpreoperativeanxietyrangesfrom11%to80%inadult

patients2,5.Preoperativeanxietycanleadtomultipledeleteriousphysiologicaleffects

including:tachycardia,arrhythmias,hypertension,increasedlevelsofpainwithdifficultyto

providepainmanagement,increasedanestheticrequirements,increasedincidenceof

postoperativenauseaandvomiting,increasedsurgicalrisks,andlongerhospitalization1,5-8.

Inorderforpractitionerstoidentifywaystoeffectivelyreducetheanxiety

experiencedbypatientsinthepreoperativeperiod,reliableandvalidinstrumentsto

measurepreoperativeanxietymustfirstbeidentified.Specificfocusonthepreoperative

periodofhospitalizationforsurgicalpatientshasnotbeenprovidedinpreviousreviewsof

anxietymeasurementinstruments.Theobjectiveofthisintegrativereviewistosynthesize

anddescribetheinstrumentsandtheirpsychometricpropertiesusedtomeasure

preoperativeanxietyinthepastdecade.

Theoreticalframework

TheStressResponseTheorywasusedasaguidetodefineacutesituationalanxiety

inthepreoperativeperiodofhospitalization.TheStressResponseTheorypostulatesthe

breakdownofacutesituationalanxietyas:thethreat(i.e.,stress);theindividualreaction

(i.e.,fear,anxiety,elation);andphysiologicalfightorflightresponseofhealthandsurvival

thatincludesthecentralnervoussystemandhormonalresponses9,10.Thetheoretical

definitionofacutesituationalanxietyguidedbytheStressResponseTheorythatwas

utilizedinthisreviewis:asubjectivefearfulfeelingofemotioninfluencedbyanimmediate

situationwhichisvariableinintensityanddurationamongpatientsinthepreoperative

41

periodofhospitalization1-4,9,10.Figure1(adaptedfromtheworkofRice,2012)represents

theunderlyingprinciplesoftheStressResponseTheoryprinciples10.

Stress(psychological,physical,andperceived)leadstoanindividualreactionas

wellasacentralnervoussystemresponseoftencommonlyknownas“fightorflight”11.

Whenastressfulsituationarisessympatheticactivationoccurs,whichsubsidesoncethe

stressfulencounterends.Inadditiontoasubsidingsympatheticactivation,

parasympatheticactivityalsoengages12.Collectivelythesetwosystemsworktogetherto

achieveautonomicnervoussystembalance12.Unfortunately,perfectbalanceisoftennot

achievedduetochronicboutsofacutestressaswellasoverarchingchronicstress.This

occurrenceoftenallowssympatheticdrivetoremainincreasedandovertimedamagesthe

vasculatureandotherregulatorysystems12,13.In1993,McEwenandStellarlabeledthis

imbalance“allostaticload”anddemonstratedthatifitisnotproperlyassessed,managed,

and,treateditcanleadtopoorhealthoutcomes14.Physiologicalindictorsfordetermining

allostaticloadandoverallhealthinclude,butarenotlimitedto,systolicanddiastolicblood

pressures,totalcholesterol,serumdihydroepiandrosterone(DHEA-S),24-hoururinary

cortisolexcretion,urinarynoradrenalineandadrenaline10.

Searchstrategy

Asystematicapproachwasusedtoreviewtheliterature.Threedatabaseswere

queried:PubMed,CumulativeIndextoNursingandAlliedHealthLiterature(CINAHL),and

PsycINFO.Inthefirststepofthesearch,keywordspreoperativeperiodandanxietywere

usedtoretrieverelevantarticlesaswellasadditionalkeywordsrelatedtotheconceptof

interestwithineachdatabase.Thetermsacute,situationalanxiety,andsurgerydidnot

yieldadditionalresults.Inthesecondstepofthesearch,thefollowingkeywordswere

42

addedtothesearches:complementarytherapyandanxietyindexinPubMed,and

instrumentsinCINAHLandPsycINFO.Inthethirdstepofthesearch,thefollowingfiltersor

limiterswereemployed:Englishlanguage,adults(18yearsandolder),andpublication

withinthelast10years.

Duringtheliteraturesearch,manystudiesrelatedtopreoperationalanxietywere

designedtoassessaspecificcomplementarytherapy.Asaresult,thekeyword

complementarytherapywasaddedtonarrowthescopeofthisliteraturereview.

Additionally,therewerethreestudiesfromthissearchthataddressedthepsychometric

propertiesofinstrumentsthatmeasurepreoperationalanxietyforapplicationinlanguages

otherthanEnglish.Thesestudieswereexcludedduetotheheterogeneityofpreoperative

clinicalsettingsbetweencountries.

Results

Thefivestudiesincludedinthisreviewallusedinstrumentstodetermineacute

situationalanxietyinthepreoperativeperiodofhospitalization:theState-TraitAnxiety

Inventory(STAI)1,StateAnxietyInventory(SAI)7,StandardVisualAnalogScaleforanxiety

(VAS)15,VisualAnalogScale(VAS)16,andAnxietySpecificToSurgeryQuestionnaire

(ASSQ)8.Noneofthestudiesreviewedreportedaguidingtheoreticalframeworkhowever

theyallreportpsycho-physiologicalresponsedata.Thepsycho-physiologicalresponses

includedallofthefollowing:BispectralIndex(BIS)monitoring1;HeartRate(HR),

RespiratoryRate(RR),DiastolicBloodPressure(DBP),andSystolicBloodPressure(SBP)

15;MeanArterialPressure(MAP)andpainscores7;HeartRateVariability(HRV)16;andthe

MultidimensionalScaleofPerceivedSocialSupport8.Fourofthefivestudieswere

conductedoutsideoftheUnitedStates.Atotalof819adultsubjectswereassessedwithin

43

the5studies.Thedescriptiondetailsofinstrumentsvariedwidelyacrossstudies.Overall,

thequalityofthestudiesrangedfrommedium(3)tolow(2)levelevidenceinformingthe

results17.Theinstruments’psychometricpropertiesofreliabilityandvalidityarereported

inTable1.

LevelsofEvidence

TheOxfordeCentreforEvidence-BasedMedicine(2011)gradethequalityofastudy

basedonahierarchyofquestionstofindthelikelybestevidence17.Thereare5levelsof

studies.TheOCEBMLevelsofEvidenceaimstoassistcliniciansinconductingarapid

appraisalofresearch.Threeofthefivestudiesarerandomizedtrialsandthusare

consideredlevel2studies(Table1).Theremainingtwostudiesareaquasi-experimental

designanddescriptivestudy,whichareconsideredlevel3studies(Table1).

Reliability

Fourofthefivestudiesreportedsomemeasureofreliability.Reliabilitydescribes

theconsistencyofaninstrumentormethodtoassignscorestosubjects3.Asasubjective

concept,acutesituationalanxietycanonlybemeasuredbyaskingthepatientabouthisor

hercurrentlevelofanxiety.Thusstabilityisoftennotexpectedandtheinternal

consistencyofatooltomeasureatransientfearfulemotionsuchasanxietyiscommonly

reportedasCronbach’salphacoefficientversussplit-halfreliability18.Twoofthefive

studiesreportedreliabilityintermsofinternalconsistencywithCronbach’salpha

coefficientscores.However,therewassignificantvariationintheCronbach’salpha

coefficientscoresreported.Anothertwoofthefivestudiesreportedthatreliabilityoftheir

instrumentwasbasedonitsuseinprevioussimilarresearch.Inanefforttoquantitatively

definereliability,thestudiesreferencedregardingreliabilitywerereviewedandadditional

44

information,ifavailable,wasaddedtotable1.Finally,oneofthefivestudiesexamineddid

notreportreliability.

Validity

Validitydescribesifaninstrumentormethodmeasureswhatitisintendedto

measure3.Ofthefivestudiesreviewed,threereportsomemeasureofvalidity.Oneofthe

fivestudiesreportedreferencedataforcriterionvalidityofVASasaninstrumentfor

measuringanxiety16.Twoofthefivestudiesreportthatthevalidityoftheirinstrumentis

basedonitsuseinprevioussimilarresearch.Inanefforttoquantitativelydefinevalidity,

thestudiesreferencedregardingvalidityfromthelast10yearswerereviewedand

additionalinformation,ifavailable,wasaddedtotable1.Theremainingtwoofthefive

studiesdonotdiscussorreportmeasuresofvalidity.Thoughnotreportedasconvergent

ordiscriminantvalidity,allfivestudiesusepsycho-physiologicalresponsesamong

participantstocorroboratethelevelofanxietymeasuredwiththestudy’sselectedscale18.

Discussion

Fiveinstrumentsthatmeasureacutesituationalanxietyinthepreoperativeperiod

ofhospitalizationmetcriteriaforinclusioninthisintegrativereview.Previousreviewson

instrumentstomeasureanxietyhavenotfocusedonthepreoperativeperiodof

hospitalizationforsurgicalpatients.Thus,thefivestudiesincludedinthisreviewrepresent

theinstrumentsused,withinthelastdecade,tomeasurepreoperativeanxiety.

Additionally,descriptionsandimplicationsoftheirpsychometricpropertiesarediscussed.

Accordingtothisliteraturereview,Spielberger’sState-TraitAnxietyInventory

(STAI)andtheVisualAnalogScale(VAS)foranxietyarethetwomostcommonlyused

instrumentstomeasureanxietyintheclinicalsetting1,7,8,15.TheState-TraitAnxiety

45

Inventorymeasuresbothstateanxiety,feelingswhensubjectedtoananxiety-provoking

stimulus,andtraitanxiety,dispositionofresponsestostressfulsituations6.Stateandtrait

anxietyareeachassessedbyanswering20itemsusinga4-pointscale.Higherscoresare

indicativeofgreateranxiety19.Historically,theinternalconsistencycoefficientshave

rangedfrom0.86to0.95,withevidencetoattesttotheconcurrentandcontextvalidityof

thescale19.TheVisualAnalogScale(VAS)foranxietyisasimpleinstrumenttomeasure

anxiety.Alonganequallydividedcontinuum(i.e.,0to10or0to100),thesubjectselects

theirlevelofanxiety.

Psychometricscoringforbothreliabilityandvalidityissparseamongtheincluded

studies.Multiplestudiesreportthatbothreliabilityandvalidityoftheinstrumentwas

basedonitsuseinpreviousresearch.Inanefforttoquantitativelydefinereliabilityand

validityoftheinstrument,thereferencescitedwithinthefivestudieswerealsoreviewed.

Unfortunately,thereferencedstudiesofferedadditionalreferencestootherstudies

regardingreliabilityandvalidityornoinformationregardingpsychometricinformationon

reliabilityorvalidityoftheinstrumentsusedinthepreoperativeperiodtoassessanxiety.

Thereforeonemustconsiderthatpreviousresultsoftheseinstrumentsmaynotgeneralize

whenusedinthepreoperativesetting.

Acutesituationalanxietyisasubjectiveconceptandcanonlybemeasuredbyasking

thepatientabouthisorhercurrentlevelofanxiety.Inorderforproviderstoreduce

measurementerrorandmakeappropriateclinicaldecisionsfromthesesubjectivereports

itisimportanttouseaninstrumentwithadequatereliabilityandvalidity.Researchers

shouldnotcontinuetoperpetuatetheuseofanxietyindiceswithoutfirstacquiringnew

dataonthereliabilityandvalidityofatoolfortheirpatientpopulationandsetting.

46

Adequatelyidentifyinganxietyandtreatinganxietyarepatient-centricconcernsas

reducingallostaticloadisimportanttooptimizepatienthealth.Acutesituationalanxietyin

thepreoperativeperiodofhospitalizationisacomplexconcept.Asaresultasinglescore

onaquestionnaireorscalemaynotencapsulateallofthepsycho-physiologicalclinical

indicatorsofanxiety.Acrossthefivestudiesreviewedthefollowingindicatorswere

captured:heartrate,heartratevariability,bloodpressure,meanarterialpressure,pain,

bispectralindex(BIS),socialsupport,andrespiratoryrate1,7,15,16.

Furtherresearchaimedatestablishingareliableandvalidinstrument(and

corroborativephysiologicalmetric)tomeasureacutesituationalanxietyinthe

preoperativeperiodofhospitalizationiswarranted.Understandingthecentralnervous

systemresponsetostressandaccuratelyassessingapatient’slevelofanxietywitha

reliableandvalidinstrumentinthepreoperativeperiodwillenableproviderstobesttailor

ananestheticplanforeachindividualpatient.Finally,researchwithintheUnitedStates

attemptingtoreduceacutesituationalanxietythroughcomplementarytherapiesinthe

preoperativeperiodofhospitalizationareintheirinfancymakingadditionalresearch

warranted.

Conclusion

Thereareonlyafewinstrumentsavailabletomeasuretheconceptofacute

situationalanxietyinthepreoperativeperiodofhospitalization.Ofthefivestudies

presented,reliabilityandvalidityarenotconsistentlyreported.Thisshouldraiseconcerns

forproviderswhowishtousetheseinstrumentstomeasurepreoperationalanxietyand

providetreatmentbasedontheinstruments’results.AsapracticingCRNA,Icanattestto

theneedforadeeperunderstandingoftheconceptofacutesituationalanxietyinthe

47

preoperativeperiodandtheneedforreliableandvalidinstrumentstomeasureit.The

physiologicalimbalancethatoccursduetoacutestressisimportantforpractitionerssince

earlydetectionandtreatmentofacutesituationalanxietyhasthepotentialtoreducethe

deleteriouseffectofanxietyonthebodyandleadtoimprovedpatientoutcomes.

48

Figure1.TheStressResponseTheory.DiagramadaptedfromRice,20129-14.

Sympathe)c/Parasympathe)c/

Imbalance/

Sympathe)c/Parasympathe)c/

Balance/

Allosta)c/Load/–//Increased/disease/

risk/

Health/&/

Survival/

Individual/Reac)on/

(Fight/or/Flight)/

Threat/(Stress)/

Instrument

Reference

Framework/

Psycho-

physiological

response

Sample

Subjects

Instrument

Descriptionand

Scoring

Reliability Validity Feasibility Levelof

Evidence17

State-Trait

AnxietyIndex

(STAI):1

Noframework

reported;BIS

monitoring

Adultsurgical

patients

undergoing

generalor

regional

anesthesia,

AnkaraTraining

andResearch

Hospitalof

Ministryof

Health,Ankara,

Turkey,n=52

Consistsoftwo20-

itemsectionsfor

stateanxiety

(STAI-S)andtrait

anxiety(STAI-T)

Reportedas:

supportedbystudiesthatdemonstratedreductionsinBISandSTAIcorrelatedwellwithanxiolysis.Correlations

betweendose

propofolforBIS

65andS-STAI

wasr2=0.033

andT-STAIwas

r2=0.067from

theoriginal

study6

Reportedas

“supportedby

studies”

20-30minutes

tocompleteon

average,40-item

questionnaire

potentiallytime

consuming

2:

prospective,

randomized,

single-

blinded,

controlled

study.

Standardvisual

analogscale

(VAS)to

measure

anxiety:15

Noframework

Reported;RR,

HR,DBP,SBP

Adultsurgical

patients

scheduledfor

abdominal

surgery,Tehran,

Iran,n=70

Visualanalogscale

from0-10to

measureanxiety,

meananxiety

scoreswere

comparedbefore

andafter

intervention

Reportedas

provenreliable

fromitsusein

severaldifferent

research

studies20-22

Reportedas

provenvalid

fromitsusein

severaldifferent

research

studies20-22;

correlation

coefficient(r)of

0.55-0.84

betweenVAS

andSTAI21

Simpletool,data

islimitedbased

ononescale

rating,easierto

useindifficult

clinical

settings21

2:

randomized

controlled

clinicaltrial.

20-item

Spielberger

StateAnxiety

Noframework

reported;MAP,

Painscores

Convenience

sampleof

womenwith

20-itemscale,

anxietylevel

scoresfromT1to

Internal

consistency

valuesforthe

Notreported 10minutesto

complete;20-

itemscale21

3:quasi-

experimental

design.

50

Scale(SAI):7 breast

malignancy

undergoing

mastectomyat

anurban

hospitalin

western

Tennessee,n=30

T2werecompared SAIwere

reportedas

0.958atT1and

0.973atT2

VisualAnalog

Scale(VAS):16

Noframework

reported;HRV

Adultswaiting

forsurgery

without

premedicationat

ametropolitan

teachinghospital

inTaiwan,

n=167

VASisa10-cm

horizontalline

markedbyvertical

linesat1cm

intervals,scores

rangefrom“not

anxiousatall”(0)

to“extremely

anxious”(10)

Notreported Report

referencedata

forcriterion

validityofVAS

formeasuring

anxiety,

correlationwith

hospitalanxiety

(r=0.28)and

STAI(r=0.5-0.6

or0.78)

Simpletool,5

secondsfor

patientto

communicate

theiranxiety

levelandpatient

canremainlying

flat

2:

randomized

controlled

clinical

study.

AnxietySpecific

toSurgery

Questionnaire

(ASSQ);8

Noframework

Reported;

Multidimensional

Scaleof

PerceivedSocial

Support

Adultpatients

havingsurgery

atauniversity

hospitalin

CentralAnatolia

regionofTurkey,

n=500

10item

questionnairewith

afive-pointscale

forscoring(1=

stronglydisagree

and5=strongly

agree)toassess

patientspecific

concernsabout

whatmayhappen

duringandafter

thesurgery

Cronbach’s

alpha=0.73for

thisstudy.

Notreported 10-item

questionnaire

3:

descriptive

study.

Table1.Dataextractionandpsychometricproperties

51

References

1. AcarHV,CuvaşÖ,CeyhanA,DikmenB.AcupunctureonYintangPointDecreasesPreoperativeAnxiety.JournalofAlternative&ComplementaryMedicine.2013;19(5):420-424.

2. MaranetsI,KainZN.Preoperativeanxietyandintraoperativeanesthetic

requirements.AnesthAnalg.1999;89(6):1346-1351.3. WaltzC,StricklandO,LenzE.Measurementinnursingandhealthresearch.4thed.

NewYork,NY:SpringerPublishingCompany;2010.4. Merriam-Webster.http://www.merriam-webster.com,2015.5. CaumoW,SchmidtAP,SchneiderCN,etal.Riskfactorsforpostoperativeanxietyin

adults.Anaesthesia.2001;56(8):720-728.6. KilHK,KimWO,ChungWY,KimGH,SeoH,HongJY.Preoperativeanxietyandpain

sensitivityareindependentpredictorsofpropofolandsevofluranerequirementsingeneralanaesthesia.BrJAnaesth.2012;108(1):119-125.

7. Binns-TurnerPG,WilsonLL,PryorER,BoydGL,PrickettCA.PerioperativeMusic

andItsEffectsonAnxiety,Hemodynamics,andPaininWomenUndergoingMastectomy.AANAJournal.2011;79(4Suppl):S21-27.

8. YilmazM,SezerH,GürlerH,BekarM.Predictorsofpreoperativeanxietyinsurgical

inpatients.JClinNurs.2012;21(7-8):956-964.9. RiceV.Theoriesofstressanditsrelationshiptohealth.HandbookofStress,Coping,

andHealth.SagePublications;2000.10. RiceVH.HandbookofStress,Coping,andHealth.2ed.ThousandOaks,CA:SAGE;

2012.11. JansenASP,NguyenXV,KarpitskiyV,MettenleiterTC,LoewyAD.Centralcommand

neuronsofthesympatheticnervoussystem:Basisofthefight-or-flightresponse.Science.1995;270(5236):644-646.

12. CharmandariE,TsigosC,ChrousosG.Endocrinologyofthestressresponse.Annual

ReviewofPhysiology.2005;67:259-284.13. Logan,JG,Barksdale,DJ.Allostasisandallostaticload:Expandingthediscourseon

stressandcardiovasculardisease.JournalofClinicalNursing.2008;17(7B):201-208.14. McEwenBS,StellarE.Stressandtheindividual.Mechanismsleadingtodisease.

ArchivesofInternalMedicine.1993;153(18):2093-2101.

52

15. ValieeS,BassampourSS,NasrabadiAN,PouresmaeilZ,MehranA.Effectof

AcupressureonPreoperativeAnxiety:AClinicalTrial.JournalofPeriAnesthesiaNursing.2012;27(4):259-266.

16. LeeK-C,ChaoY-H,YiinJ-J,ChiangP-Y,ChaoY-F.Effectivenessofdifferentmusic-

playingdevicesforreducingpreoperativeanxiety:Aclinicalcontrolstudy.InternationalJournalofNursingStudies.2011;48(10):1180-1187.

17. OCEBMLevelsofEvidenceWorkingGroup."TheOxfordLevelsofEvidence2".

OxfordCentreforEvidence-BasedMedicine.http://www.cebm.net/index.aspz?o=5653.

18. DiIorioCK.Measurementinhealthbehavior:Methodsforresearchandevaluation.

SanFrancisco,CA:Jossey-Bass;2005.19. AmericanPsychologyAssociation.TheState-TraitAnxietyInventory(STAI).2015;

http://www.apa.org.20. AgarwalA,RanjanR,DhiraajS,LakraA,KumarM,SinghU.Acupressurefor

preventionofpre-operativeanxiety:aprospective,randomised,placebocontrolledstudy.Anaesthesia.2005;60(10):978-981.

21. KoberA,ScheckT,SchubertB,etal.Auricularacupressureasatreatmentfor

anxietyinprehospitaltransportsettings.Anesthesiology.2003;98(6):1328-1332.22. FassoulakiA,ParaskevaA,PatrisK,PourgieziT,KostopanagiotouG.Pressure

appliedontheextra1acupuncturepointreducesbispectralindexvaluesandstressinvolunteers.AnesthAnalg.2003;96(3):885-890,tableofcontents.

53

ManuscriptIII

Aromatherapyforpreoperativeanxietyamongfemalebreastsurgerypatients:Afeasibilitystudy

CandaceB.Jaruzel,MSN,APRN,CRNAPhDCandidate

MedicalUniversityofSouthCarolinaCollegeofNursing

PhDDissertationCommittee:

Chair:TeresaKelechi,PhD,RN,FAAN

AmandaFaircloth,PhD,DNAP,CRNA

MathewGregoski,PhD,MS

MarinaMueller,PhD

54

Abstract

Objective:Acutesituationalanxietycanaffectasignificantproportionofadultpatients

undergoingsurgery.Failuretoeffectivelymanageanxietyintheperioperativeperiodcan

leadtomultipleadverseoutcomes.Thepurposeofthisstudywastodeterminethe

feasibilityofprovidingaromatherapyforanxietyduringthepreoperativeperiod.Methods:

Thirtyfemalepatientsscheduledforbreastsurgerywererecruitedandenrolledinthe

studyovera6-weekperiod.Feasibilitywasassessedthroughmeasuringparticipantand

providerresponsesthatweremappedtotheRE-AIM(Reach,Effectiveness,Adoption,

Implementation,Maintenance)frameworkandanxietywasmeasuredwitha10-cmvisual

analogscale(VAS).Results:Themajorityofparticipants(81.8%,n=18)andproviders

(30%,n=3)reportedbeingextremelylikelytouseororderanaromatherapypatchinthe

future.Therewasastatisticallysignificantdecreasefrombaselineanxietytofinalanxiety

measurements(M=5.7,SD=2.6vs.M=4.2,SD=3.3;t[29]=2.3,p=0.03).Conclusion:

Aromatherapyisafeasibleandpotentiallyefficaciousinterventiontoreduceanxietyinthe

preoperativeperiodofsurgeryforfemalepatientsundergoingbreastsurgeryandmay

improvetheirpreoperativeexperience.Futureresearchwarrantsarandomizedcontrolled

clinicalstudy.

Keywords:anxiety,preoperative,aromatherapy,complementarytherapy,breast

surgery

55

Introduction

Acutesituationalanxietyisasubjectivefeelingofanunpleasant,fearfulemotionor

uneasinessthatisinfluencedbytheimmediatesituation1-4.Theintensityanddurationof

acutesituationalanxietycanvaryamongpatientsinthepreoperativeperiodbefore

surgery2.Previousstudiesestimatethattheincidenceofpreoperativeanxietyrangesfrom

11%to80%inadultpatients2,5.InaccordancewiththeStressResponseTheory6,7,

numerousdeleteriouseffectsofuntreatedanxietyduringthisperiodhavebeen

documentedincludingtachycardia,arrhythmias,hypertension,increasedlevelsofpain,

difficultywithprovidingpainmanagement,increasedanestheticrequirements,higher

incidenceofpostoperativenauseaandvomiting,highersurgicalrisks,andlonger

hospitalization1,5,8-10.AccordingtotheInstituteofMedicine11,amajorgoalofpatient-

centeredcareistoassessnegativebio-behavioralchangesassociatedwithstressandto

implementstrategiestoalleviatethosechanges.Traditionalanxietytreatmentincludes

medicationssuchastheanxiolytic,midazolam,whichhasbeenshowntoproducenegative

physiologicaleffectssuchasdelayedawakening,nauseaandvomiting,andotheradverse

sideeffects9.Non-pharmacologicalinterventionssuchasmusic,acupuncture,relaxation

techniques,andaromatherapyhavebeenshowntoreduceand/oralleviateanxietywithout

anysequelae1,9,12,13.

AromatherapyforPreoperativeAnxiety

Aromatherapyisalow-riskcomplementarytherapythatusesnatural,plant

essences(e.g.lavender,spearmint,peppermint,citrus)fortherapeuticpurposes14,15.

Essentialoilsmayprovideamoregentletreatmentoptionwithsignificantpsychological

andphysiologicbenefits,withouttheuseofartificiallycreatedanxiolyticchemicals15,16.

56

Fewstudiestodatehaveassessedtheuseofaromatherapytoreduceanxietyinthe

preoperativeperiodofsurgery.Aromatherapyoffersmultiplebenefitsoverother

complementarytherapies(e.g.music,acupuncture,andrelaxationtechniques)as

aromatherapydoesnotrequireactivepatientparticipation,supplementalequipment,new

skillssets,oradditionalpersonnelforimplementation.Forthisstudy,anaromatherapy

skinpatchwasselectedasacomplementarymodalitytoassesspreliminarysignalsof

efficacyonanxietyreliefforfemalesurgicalpatientsundergoingbreastprocedures.

PriorAromatherapyResearch

Aromatherapyisgainingpopularityasacomplementarytherapystrategytomanage

anxiety.Overthelastdecade,abodyofevidencehasemergedsuggestingthat

aromatherapypositivelyaffectssurgicalpatientsinthepreoperativesetting.In2009,

Braden,Reichow,andHalm17usedanexperimentalpretest/posttestdesigntoinvestigate

theeffectofessentialoilsonpreoperativeanxietyin150adultpatients(75femalesand75

females)undergoinggastrointestinal,genitourinary,andorthopedicprocedures.They

foundthatthetopicaluseoftheessentialoillavandinincomparisontothecontroland

sham(jojobaoil)groupswasstatisticallysignificantinloweringpreoperativeanxiety(p=

0.01)usingaVisualAnalogScale(VAS)atthetimeoftransfertotheOperatingRoom(Mean

Scores=29.96lavandingroup,37.48controlgroup,35.78jojobagroup)18.

In2011,Fayazi,Babashahi,andRezaei18conductedaclinicalstudyontheeffectof

inhalationaromatherapyonpreoperativeanxietywith72adultpatientsscheduledfor

heartandabdominalsurgery.Theyreportedastatisticallysignificantdifferenceinanxiety

levels(p=0.001)ontheState-TraitAnxietyIndex(STAI)betweenthecasegroupand

controlgroupaftertwentyminutesofinhalationwithahandkerchiefcontaininglavandula

57

(Meandifferences=12.388casegroup,2.416controlgroup)19.In2013,Nietal.13

conductedarandomizedcontrolledtrialontheanxiolyticeffectofaromatherapyon109

patientsawaitingambulatorysurgery.Theplantoilbergamotwasdiffusedintheward

throughanultrasonicaromadiffuserdevice.Theinvestigatorsreportedastatistically

significantdecreaseinSTAIscoresinthebergamotessentialoilgroupcomparedtothe

controlgroupinpatientswithoutprevioussurgicalexperience(-3.0versus-2.0,p=0.021)

andinpatientswithprevioussurgicalexperience(-4.0versus-1.0,p=0.005).Additionally,

heartrate(HR)(-6.0beats/min,p=0.015),systolicbloodpressure(-11.0mmHg,p<

0.001),anddiastolicbloodpressure(-5.0mmHg,p=0.012)significantlydecreasedinthe

bergamotgroup13.

Whilethesestudiessuggestthattheuseofaromatherapyasananxiolyticagenthas

beenbeneficialforpatientsintheperioperativeperiod,thereisnostandarddelivery

modalityforaromatherapy.Theinhalationtechnologyandvapordeliveryaromatherapy

patchbyBioesse®Technologies,LLCisanewandinnovativemodalityusedtoconsistently

deliveraromaticessentialoilstosurgicalpatientsinthepreoperativeperiodof

hospitalization16.Thepatchcontains100%naturallypurelavender(Lavandula

Angustfolie)essentialoil16.Thedesignofthepatchincludesanocclusivebarriertoprevent

oilsfromcontactingorbeingabsorbedthroughtheskinbutallowsolfactoryscent

inhalationwhichactivatesreceptorsitesinthebrain16.

FemaleSurgicalPatients

Anumberofstudiesreportthatfemalesurgicalpatientsexperiencemore

preoperativeanxietycomparedtotheirmalecounterparts10,19-21.Additionally,anxietyis

increasedwhenfacingaprocedurewithaknowncancerdiagnosisoronethathasthe

58

potentialforacancerdiagnosis5,9.Fewstudiestodatehavetargetedpreoperativeanxiety

infemalepatientsundergoinglumpectomy,mastectomy,sentinelnodebiopsyoraxillary

nodedissectionprocedures;thusmethodsthatarebestsuitedtoreduceanxietyinthis

patientpopulationremainpoorlyunderstood.

Priorresearchsuggeststhatthereisnostandardassessmentinstrumentforanxiety

amongfemalesurgicalpatients.Despitetheavailabilityofinstrumentstomeasureanxiety,

thereiscurrentlynoroutineassessmentofanxietyusingareliableandvalidinstrumentin

thepreoperativeperiodatthismedicalcenter.Thislackofstandardizedassessmenthas

thepotentialtoleadtoinadequateandineffectiveanxietymanagementinthepreoperative

periodthatcouldproducenegativepsycho-physiologicaloutcomesforfemalesurgical

patients.

Purpose

Thisstudyevaluatedthefeasibilityofprovidinglavenderaromatherapythrougha

sustained-releasepatchappliedtothechestandtheuseofaVAStomeasureanxietylevels

duringthepreoperativeperiodforfemalepatientsscheduledforbreastsurgery.TheRE-

AIM(Reach,Effectiveness,Adoption,Implementation,andMaintenance)frameworkwas

selectedtoguidethefeasibilityassessmentprocess22,23.Thestudyaimswereto1)evaluate

anddeterminethefeasibilityofusinganaromatherapypatchinthepreoperativeperiodof

surgeryforanxietyusingtheRE-AIMframeworkbyassessingrecruitment,retention,

adherence,andadoption;and2)collectdataonpreliminarysignalsofefficacyonanxiety

measuredwithaVASandphysiologicalsignsofanxietyincludingHRandmeanarterial

bloodpressure(MAP).

TheoreticalFramework

59

ThetheoreticalframeworkunderlyingthisstudyisHansSelye’sGeneralAdaptation

SyndromeTheoryofStress7.Selye’smodeldescribesathree-stagebodilyresponsetoa

stressor:1)alarm,2)resistance,and,3)exhaustion7.Duringthealarmstage,the

sympatheticnervoussystemisactivatedresultinginphysiologicalchangesthatincludebut

arenotlimitedtoincreasedrespirations,heartrate,bloodpressure,andperspiration7.

Duringtheresistancestage,theparasympatheticnervoussystemisactivatedinanattempt

torestorehomeostaticbalance7.Ifahomeostaticbalancecannotberestored,exhaustion

occursandthebodyissusceptibletodiseaseanddeath7.Thegoalisadaptivecopingin

responsetothestressortobalancethebiological,psychologicalandsocialprocessesto

resolvethestressresponse7.Thisstudyassessedthefeasibilityofprovidingan

aromatherapyinterventiontoassistwithadaptivecopingforpreoperativeanxietyin

femalepatientsscheduledforbreastsurgery.

Methods

StudyOverview

Thisstudyevaluatedthefeasibilityofusinganaromatherapypatchandmeasuring

anxietyanditsphysiologicalindicatorsinthepreoperativeperiodofsurgeryforfemale

patientsscheduledforbreastsurgery.ThestudywasconductedattheAshleyRiverTower

HospitalOperatingRoomattheMedicalUniversityofSouthCarolina(MUSC).TheAshley

RiverTowerOperatingRoomperformsapproximately3,500casesperyear.Thisstudywas

conductedinJanuary2016throughMarch2016.ThestudywasapprovedbytheMUSC

InstitutionalReviewBoardandwritteninformedconsentwasobtained.

Sample,SettingandRecruitment

60

Femalepatientsscheduledforlumpectomyand/ormastectomyand/orsentinel

nodebiopsyand/oraxillarynodedissectionwereinvitedtoparticipateinthestudyuntila

conveniencesampleof30patientswasreached.Approximatelytenlumpectomyand/or

mastectomyand/orsentinelnodebiopsyand/oraxillarynodedissectioncasesare

scheduledperweek.Weanticipatedthat50%ofpatientsscheduledfortheseprocedures

wouldbeeligibleandwouldconsentforenrollmentresultinginapproximatelysixweeksof

recruitmenttoreachthetargetsamplesizeof30participants.Thesamplesizeof30female

participantswasbasedonthepragmaticsofrecruitmentandnumbersneededtoassess

feasibilityaccordingtoLeonetal24.

InclusioncriteriaincludedEnglish-speaking,femalepatients,aged18yearsorolder

presentingforlumpectomyand/ormastectomyand/orsentinelnodebiopsyand/or

axillarynodedissectionsurgery.Exclusioncriteriaincludedknownallergiestolavender

and/oradhesivetape,acuteseriousmedicalconditionsdeemingthesurgeryanemergency

atthetimeofenrollment,cognitive,mental,orvisualimpairmentsuchasadiagnosisof

blindness,anosmiaordementiainthemedicalrecordthatwouldpreventparticipationin

studycomponents,andasthmaoranyreactiveairwaydiseasediagnosisthatcouldbe

exacerbatedbythearomatherapypatch.ThepreoperativeRegisteredNurse(RN)

introducedfemalesurgicalpatientsscheduledforanyoftheappropriateprocedurestothe

studyduringthestandardphonecalltwodaysbeforesurgeryusingthefollowingscript:

“Oneofournurseanesthetistsisconductingastudyonanxietyandaromatherapyduring

thepreoperativeperiod,wouldyoubeinterestedinparticipatinginthestudy?”Those

patientswhoindicatedtheirinterestinparticipatinginthestudywereapproached

61

regardingenrollmentintothestudyuponarrivaltotheirassignedpreoperativebayonthe

dayofsurgery.

Enrolledparticipantsreceivedthearomatherapypatchprotocolthatincluded

placementofalavenderBioesse®16aromatherapypatchbythepreoperativeRNduring

routinemonitorandaccessoryplacement.Participantsalsoreceivedstandardpreoperative

carewhichincluded,butwasnotlimitedto,patientidentificationwithahospitalbracelet,

changingintoahospitalgown,preoperativevitalsignmeasurementwithadisposable

bloodpressurecuffandpulseoximetryprobe,andtheinitiationofpreoperativeordersets.

Measures

Demographicdataincludingage,race/ethnicity,maritalstatus,andnumberof

childrenandclinicalcharacteristicssuchasdiagnosis,surgeryandsurgicalhistory,

AmericanSocietyofAnesthesiologists(ASA)physicalstatusclassificationwhichisagrade

ofpreoperativehealthforthesurgicalpatient25,bodymassindexinkg/m2(BMI),current

anxiolytic,sedativeand/orantidepressantmedications,andsmokingstatuswerecollected

fromtheparticipantand/ortheparticipant’smedicalrecord.Feasibilitywasassessed

throughthefivedimensions(Reach,Effectiveness,Adoption,Implementation,

Maintenance)oftheRE-AIMframework.Studydataandparticipantandprovider

responsestoquestionsweremappedtothefivedimensions.Participantsreceivedafollow

upphonecallfromthePIwithin24-hoursoftheirdischargefromthepost-anesthesiacareunit

(PACU)andprovidersreceivedapost-studysurveyviaemailwithin48-hoursofstudy

completiontoassessfeasibility(Appendix1&2).

RE-AIMforfeasibility.Reach,definedasthenumberofindividualswhowerewillingto

participateinthestudywasmeasuredthroughstudyrecruitmentandattrition.

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Effectivenessmeasuredtheimpactoftheintervention.Thisdimensionwasassessedduring

thefollowupphonecallbyaskingparticipantstorateiftheybelievedthepatchwashelpful

onascalefrom0(nothelpfulatall)to5(extremelyhelpful).Adoptionwasdefinedasthe

numberofindividuals,participantsandproviders,whowerewillingtoinitiatethe

protocol.Thisdimensionwasassessedduringthefollowupphonecallsbyasking

participantstoratetheirlikelinesstoparticipateinanaromatherapystudyinthefuture.

ProviderswereaskedtoratetheirlikelinesstoadoptaVASforanxietyassessmentandto

useanaromatherapypatchforpatientsexperiencingacutepreoperativeanxiety.

Implementationexaminedthestudyprotocol.Thisdimensionwasassessedduringthe

followupphonecallwithparticipantsbyaskingiftheyhadanyrecommendationsforthe

study.Duringthepost-studysurvey,providerswereaskediftheyidentifiedanyproblems

withimplementationofthestudyprotocol,iftheyhadanyrecommendationsforthestudy,

andifanyproblemswereidentifiedwithpatchplacementorremoval.Maintenancewas

definedastheextenttowhichtheprotocolmaybecomeapartofroutinepractice.This

dimensionwasassessedduringthepost-studysurveybyaskingproviderstoratetheir

likelinesstouseanaromatherapypatchforpatient’sexperiencingacutepreoperative

anxietyonascalefrom0(notlikelyatall)to5(extremelylikely).Additionally,participants

andproviderswereaskedtodescribethescentofthepatchasmild,moderateorstrong.

Anxiety.Patients’anxietylevelswereassessedbytheprincipalinvestigator(PI)usinga

10-cmVAS.Thescalewasanchoredoneachendwithbothnumericandverbalindicators

(e.g.,0=noanxietyand10=extremeanxiety)(Appendix3).Astandardrulerwasusedto

measuremarksbetween0and10incentimeterstoonedecimalplace.Theparticipantwas

askedtoindicatetheircurrentlevelofanxietybydrawingasingleverticallinedirectlyon

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the10-cmVASatbaselinepriortothepatchbeingplacedonthechestbythepreoperative

RNandthenevery15minutesafterpatchplacementuntilthetimeofanesthesiastart.

Anesthesiastartwasdefinedasarrivaloftheanesthesiaprovider(e.g.,CertifiedRegistered

NurseAnesthetist(CRNA),anesthesiaresident,anesthesiologist)atthebedsidefortransfer

totheoperatingroomand/oradministrationofananxiolyticorregionalanesthetic.

VitalSigns.HRinbeatsperminute(bpm)andMAPmeasurementsinmillimetersof

mercury(mmHg)weremonitoredandrecordedbythePIfromthepreoperativemonitors

atthesame15-minuteintervalastheVAS.ThePIremovedthepatchfromtheparticipants’

chestatthetimeofanesthesiastart.

DataCaptureandStatisticalAnalysis

StudydatawereenteredintoResearchElectronicDataCapture(REDCap)asecure,

web-basedapplicationdesignedtosupportdatacaptureforresearchstudiesthatprovides:

1)anintuitiveinterfaceforvalidateddataentry;2)audittrailsfortrackingdata

manipulationandexportprocedures;3)automatedexportproceduresforseamlessdata

downloadstocommonstatisticalpackages;and4)proceduresforimportingdatafrom

externalsources26.

DatawereanalyzedusingstatisticalsoftwareSPSS27Version23.Thestudysample

wascharacterizedusingdescriptivestatisticalanalysesfordemographicandclinical

factors.Measuresoffeasibilityincludingreach,effectiveness,adoption,implementation,

andmaintenancewerereportedasproportionsforcategoricalmeasures;continuous

measureswerereportedasmeansandstandarddeviations.Baselineandfinal

measurementsofVASandVSmeasurementswerereportedasmeansandstandard

deviationswiththeir95%confidenceintervals.Pairedsamplet-testswereconductedto

64

comparethedifferencesbetweenthemeansofbaselineandfinalmeasurementsofVASand

VSmeasurements.Commentsfrombothparticipantsandprovidersweresummarized.

Results

Demographics

Duringthesix-weekrecruitmentperiod,34potentiallyeligiblefemalepatients

scheduledforsurgerywereapproachedandaskedtoparticipateinthestudy.Thirtyfemale

participants(88%)werescreenedeligibleandenrolledinthestudy.Themeanageofthe

participantswas52.3years±16.4witharangeof18yearsto89years(Table1).Themean

BMIwas29.1kg/m2±6.9(Table1).Theracialandethnicenrollmentprofilewas66.7%

White(n=20),26.7%BlackorAfricanAmerican(n=8),6.7%Asian(n=2),and96.7%not

HispanicorLatino(n=29).Diagnosesincluded46.7%malignantneoplasm,breast(n=14),

3.3%benignneoplasm,breast(n=1),and50%other(n=15;Table1).

Maritalstatusincluded56.7%married(n=17),26.7%notmarried(n=8),and16.7%

divorced(n=5).Thenumberofchildrenrangedfrom69.9%(n=21)with0-2children,to

26.7%(n=8)with3-4childrento3.3%(n=1)withgreaterthan5children.ParticipantASA

physicalstatusclassificationforpreoperativehealthrangedfromI(healthypatient)toIII

(severesystemicdisease)25(I=6.7%(n=2),II=70%(n=21),III=23.3%(n=7)).Smoking

statusincluded66.7%neversmoked(n=20),20%quitsmoking>1yearago(n=6),and

13.3%currentsmoker(n=4;Table1).Thirteenparticipants(43%)hadactiveprescriptions

forananxiolytic,sedativeand/orantidepressant.

FeasibilityAssessment

Participantswaitedinthepreoperativeareaanaverageof78.7±31.9minutes.The

preoperativetimeforparticipants,whichisdefinedasarrivalinthepreoperativebayto

65

anesthesiastart,rangedfrom30to168minutes.Theaverageamountoftimethatthe

lavenderaromatherapypatchwaswornbyparticipantswas58.1±31.4minutes.Thetotal

patchtimeforparticipants,whichisdefinedaspatchplacementtopatchremoval,ranged

from9to152minutes.

TheRE-AIMdimensions,definitions,assessmentmeasuresandresultsare

presentedinTable2.Forreach,29participants(97%)completedtheentirepreoperative

period.Oneparticipant(3%)requestedthatthepatchplacementberemovedpriortothe

first15-minuteassessmentduetothepatchscentbeing“toostrong”afterchemotherapy.

All30participantsagreedtoafollowupphonecallbut8participants(26.7%)couldnotbe

reachedviaphonewithin24-hoursofPACUdischarge.Twenty-twoparticipants(73.3%)

completedthefollowupphonecallportionofthestudy.Twelveproviders,8RNsand4

surgeons,participatedinthestudy;ofthose,tenproviders(83%),8RNsand2surgeons,

completedthepost-studysurvey.Noadverseeventswerereportedinthepreoperative

period,followupphonecall,orpost-studysurveyportionsofthestudy.

Theeffectivenessratingsrangedfrom0(nothelpfulatall)to5(extremelyhelpful).

Themajority(81.7%)ofeffectivenessratingsreportedbyparticipantswere3(13.6%;

n=3),4(13.6%;n=3),and5(54.5%;n=12).Theadoptionratingsrangedfrom0(notlikely

atall)to5(extremelylikely).Themajorityofadoptionratingsreportedbyparticipants

were5(81.8%;n=18).Themajority(90%)ofratingsreportedbyprovidersforthe

adoptionofaVASinstrumentwere0(40%;n=4),1(10%;n=1),2(20%;n=2),and3(20%;

n=2).Foradoptingtheuseofanaromatherapypatch,themajority(70%)ofratings

reportedbyproviderswere3(20%;n=2),4(20%;n=2),and5(30%;n=3;Table3).

66

Forimplementation,41%ofparticipantsand10%ofprovidersreported

recommendationsforthestudy.Therecommendationsincluded“alongeraromatherapy

patchtime”;“notenoughpreoperativetimetogetthefullbenefitofthetherapy”;“additionof

otheraesthetics(i.e.,lighting,music,additionalaromas,etc.)inthepreoperativesetting”;

“participantsenjoyedhavingtheoption”;“choiceofsiteotherthanthechestforpatch

placement”;and“aftersurgerywouldbeanicetimeforittoo”(Table2).Themaintenance

ratingsofthescentforparticipantswere22.7%(n=5)mild,54.5%(n=12)moderate,and

22.7%(n=5)strongwhereastheproviders’ratingsofthescentwere50%(n=4)mild,25%

moderate(n=2),and25%(n=2)strong.

Impactmeasures

Meanbaseline,finalandchangeinVAS,HRandMAPmeasurementswiththeir

means,standarddeviations,and95%confidenceintervalsarepresentedinTable3.There

wasasignificantdecreaseintheanxietyVASmeasurementsfrombaselinetofinalscores

(M=5.7cm,SD=2.6cmvs.M=4.2cm,SD=3.3cm,p=0.03;Table3).NosignificantchangeinHR

orMAPfrombaselinetofinalmeasurementwasobservedforthissample(M=76.1bpm,

SD=12.9bpmvs.M=75.9bpm,SD=12.0bpm,p=0.922)and(M=87.1mmHg,SD=13.7mmHg

vs.M=84.5mmHg,SD=12.3mmHg,p=0.134;Table3)respectively.

Discussion

Theaimsofthisstudyweretoassessthefeasibilityofusinganaromatherapypatch

inthepreoperativeperiodandtoexaminepreliminarysignalsofefficacyonreducing

anxietywithaVASandphysiologicalsignsofanxietyincludingHRandMAPinasampleof

femalepatientsundergoingbreastsurgeryprocedures.Demographicdatademonstrated

67

thatawiderangeoffemales,fromteenstooctogenarians,wereinterestedinusing

aromatherapytoaugmentpreoperativeanxiety.

ThemeanBMIof29.1kg/m2forthisstudysampleindicatedanoverweightpatient

population28.TheCentersforDiseaseControlandPreventionreportthatobesepeopleare

atanincreasedriskforanumberofdiseasesandhealthconditionswhichinclude,butare

notlimitedto,breastcancerandmentalillnesssuchasdepressionandanxiety28-31.

Previousresearchonperioperativeandpostoperativeanxietysuggeststhataknown

cancerdiagnosisorthepotentialforadiagnosisofcancerwillincreaseanxiety5,9.Tobetter

understandtheassociationbetweenacancerdiagnosisandacutepreoperativeanxiety

furtherresearchisneeded.

Socialsupportsystemsareapartoftheadaptivecopingprocesstoastressor7.Inan

efforttodetermineavailablesupportsystemsofparticipants,informationonmaritalstatus

andnumberofchildrenwascollected.However,allparticipantshadvisitors,eitherfamily

membersorfriends,withthemforsupportonthedayofsurgeryinthepreoperativearea.

Thisdemonstratesthattheparticipantsunderstoodtheimportanceofhavingtheirsupport

systemwiththemduringthepreoperativeperiodofsurgery.Additionally,thehealthcare

teamencouragespreoperativevisitors.Thesurgeonspeakswiththepatientandtheir

familymember(s)and/orfriend(s)priortosurgeryandthenagaintothepre-determined

supportsystemaftersurgery.Afuturestudyshouldaddresstowhatextentsupport

systemsinthepreoperativeperiodinfluenceanxiety.

FeasibilitywasevaluatedanddeterminedthroughthefivedimensionsoftheRE-

AIMframework.Datafromthisstudydemonstratedthattheapproachestorecruitment,

retention,adherenceandadoptionwerefeasibleandacceptabletoparticipantsand

68

providers.Inparticular,therecruitmentapproachinwhichtheRNsintroducedthestudyto

patientsduringthepreoperativecallwasfoundtobeasuccessfulstrategy.Thismethodof

recruitmentispromisingforcomplementarytherapystudiesinthepreoperativeperiodof

surgery.Additionally,enrollingparticipantsonthedayofsurgeryintheirpreoperativebay

wasasuccessfulstrategy.However,enrollingthempriortothemchangingintotheir

hospitalgownmayhavedelayedpatchplacement.Inanefforttomaximizethetotal

aromatherapypatchtimeforeachparticipant,thepreoperativeRNswerediligentin

placingthepatchassoonasreasonablypossible.Theproviderstruly“boughtin”tothe

studyproceduresandwereinstrumentaltothesuccessofthisstudy.

Afterreceivinganin-serviceonthestudyprotocol,allofthepreoperativeRNswere

abletofollowthearomatherapypatchprotocol.Thepatchwasplacedwiththetopofthe

patchsittingatthesuprasternalnotchusingthemanufacturerecommendationforbest

patchadhesion16.Thismodeofdeliveryisconsistentandholdsbetterpromisecompared

topastdeliverymodalitiesofdiffusers,handkerchiefdousedwithanessentialoil,ortopical

application13,17,18.Inobservingeachpatchplacement,thePInotedthatsomeparticipants

wouldcommenttotheRN(i.e.,“Thatsmellsgood;Icansmellit,That’snice”)onthescentof

thepatchduringplacement.Totalpreoperativetimeandtotalpatchtimevaried

considerableforeachparticipantwhichmayhavecontributedtoalessthanoptimal

reductioninanxietyforparticipants.

Theeffectivenessofthepatchwasself-reportedbyparticipantsandthemajorityof

participantsratedtheimpactofthearomatherapypatchasextremelyhelpful.Someofthe

participants’commentsincluded“awelcomeddistraction”;“veryimpressed”;“Ilikedhaving

theoption”;“veryrelaxing”;“enjoyedthescent”;“soothing”;“Ibelieveinlavender”;and“the

69

doctorloveditaswell”.Oneoftheproviderscommentedthattheywouldbehappytooffer

thistoalloftheirpatients.Consistentwiththepreviousaromatherapyresearchfindingsin

thepreoperativeperiod,therewasasignificantdecreaseinanxietyVASscoresfrom

baselinetofinalmeasurement.Whilenotstatisticallysignificant,thephysiologicalsignsof

anxietyincludingHRandMAPmeasurementsindicatedatrendtowarddecreasesinmean

HRandMAPfrombaselinetofinalmeasurement.Detectingstatisticallysignificant

differencesintheseoutcomesnecessitatesalargersamplesizewithadequatepowerand

moresensitivephysiologicalindicatorssuchasheartratevariability.

Allparticipantscompletedthe10-cmVASwithoutdifficulty.Thescaleallowedthem

toindicatetheircurrentlevelofanxietyinsteadofstatingarandomnumber.One

participantcommented,“it[theVAS]didletmeknowthattheclosertime[tosurgery],Iwas

gettinganxiousandIwasabletotellsomebody.Iusuallykeepthattomyself.”Takingthe

recommendationsfromboththeparticipantsandproviders,thisfeasibilitystudyhasset

thestagefortheadoptionofasustained-releasearomatherapypatchandutilizationofa

VASforanxietymeasurementintoroutinepreoperativepractice.

Limitations.Alimitationtothisstudyisthesmallconveniencesampleandtheuseofonly

onepreoperativelocation.Additionallimitationsincludetheinabilitytostandardize

preoperativetimesandpatchtimeapplication,theinabilitytocontrolfortheschedule

timingofsurgery,thedifferencesinpreoperativebayassignment,thenumberofattempts

necessaryforIVplacement,andthenumberofprovidersthatvisitthepatientinthe

preoperativeperiod.ThePI’sfieldnotesindicatedthatcertainpreoperativebaysare

predisposedtomoretrafficandnoiseandthatmultipleproviders(i.e.,PreoperativeRN,

operatingroomRN,surgicalresidents,medicalstudents,CRNA,StudentRegisteredNurse

70

Anesthetist,anesthesiologist,andsurgeons)visitedtheparticipants.Thearomatherapy

patchscentisanotherconsideration.Thescentoflavendermaynotappealtoall

participantsorproviders.Havingadditionalaromatherapypatchscentsavailableshouldbe

aconsiderationforfutureresearch.Despitetheselimitations,thisstudysupportsthata

sustained-releasearomatherapypatchisafeasible,andpotentiallyefficacious,intervention

toreducepreoperativeanxietyinfemalepatientundergoingbreastsurgeryandmay

improvetheirpreoperativeexperience.

Conclusion

Thisfeasibilitystudyprovidesthefirststeptowardunderstandingtheroleand

impactofaromatherapyonpreoperativeanxietyreduction.Furtherresearchisneededto

addresstheexperienceofpreoperativeanxietyandthechallengesofmanaging

preoperativeanxiety.Ourinterdisciplinaryteamofnurses,anesthesiaproviders,and

surgeonsiswellpositionedtocontinueworkinthisareaincludingafuturerandomized

controlledtrialtodeterminetheeffectofasustained-releasearomatherapypatchon

preoperativeanxiety.

71

References

1. AcarHV,CuvaşÖ,CeyhanA,DikmenB.AcupunctureonYintangPointDecreases

PreoperativeAnxiety.JournalofAlternative&ComplementaryMedicine.2013;19(5):420-424.

2. MaranetsI,KainZN.Preoperativeanxietyandintraoperativeanestheticrequirements.AnesthAnalg.1999;89(6):1346-1351.

3. WaltzC,StricklandO,LenzE.Measurementinnursingandhealthresearch.4thed.NewYork,NY:SpringerPublishingCompany;2010.

4. Merriam-Webster.com.http://www.merriam-webster.com,2015.5. CaumoW,SchmidtAP,SchneiderCN,etal.Riskfactorsforpostoperativeanxietyin

adults.Anaesthesia.2001;56(8):720-728.6. RiceV.Theoriesofstressanditsrelationshiptohealth.HandbookofStress,Coping,

andHealth.SagePublications;2000.7. RiceVH.HandbookofStress,Coping,andHealth.2ed.ThousandOaks,CA:SAGE;

2012.8. KilHK,KimWO,ChungWY,KimGH,SeoH,HongJY.Preoperativeanxietyandpain

sensitivityareindependentpredictorsofpropofolandsevofluranerequirementsingeneralanaesthesia.BrJAnaesth.2012;108(1):119-125.

9. Binns-TurnerPG,WilsonLL,PryorER,BoydGL,PrickettCA.PerioperativeMusicandItsEffectsonAnxiety,Hemodynamics,andPaininWomenUndergoingMastectomy.AANAJournal.2011;79(4Suppl):S21-27.

10. YilmazM,SezerH,GürlerH,BekarM.Predictorsofpreoperativeanxietyinsurgicalinpatients.JClinNurs.2012;21(7-8):956-964.

11. MedicineIo.HealthandBehavior:Theinterplayofbiological,behavioral,andsocietalinfluences.2001,2016.

12. WagnerD,ByrneM,KolcabaK.Effectsofcomfortwarmingonpreoperativepatients.AORNJ.2006;84(3):427-448.

13. NiCH,HouWH,KaoCC,etal.Theanxiolyticeffectofaromatherapyonpatientsawaitingambulatorysurgery:arandomizedcontrolledtrial.EvidBasedComplementAlternatMed.2013;2013:927419.

14. SteaS,BeraudiA,DePasqualeD.Essentialoilsforcomplementarytreatmentofsurgicalpatients:stateoftheart.EvidBasedComplementAlternatMed.2014;2014:726341.

15. PerryR,TerryR,WatsonLK,ErnstE.Islavenderananxiolyticdrug?Asystematicreviewofrandomisedclinicaltrials.Phytomedicine.2012;19(8-9):825-835.

16. BioesseTechnologies,Inc.2013.AccessedMarch14,2016,2016.17. BradenR,ReichowS,HalmMA.Theuseoftheessentialoillavandintoreduce

preoperativeanxietyinsurgicalpatients.JournalofPeriAnesthesiaNursing.2009;24(6):348-355.

18. FayaziS,BabashahiM,RezaeiM.Theeffectofinhalationaromatherapyonanxietylevelofthepatientsinpreoperativeperiod.IranJNursMidwiferyRes.2011;16(4):278-283.

19. MatthiasAT,SamarasekeraDN.Preoperativeanxietyinsurgicalpatients-experienceofasingleunit.ActaAnaesthesiolTaiwan.2012;50(1):3-6.

72

20. MitchellM.Influenceofgenderandanaesthesiatypeondaysurgeryanxiety.JournalofAdvancedNursing.2012;68(5):1014-1025.

21. SearsSR,BoltonS,BellKL.Evaluationof"StepstoSurgicalSuccess"(STEPS):aholisticperioperativemedicineprogramtomanagepainandanxietyrelatedtosurgery.HolistNursPract.2013;27(6):349-357.

22. GlasgowR,VogtT,BolesS.Evaluatingthepubichealthimpactofhealthpromotioninterventions:TheRE-AIMframework.AmericanJournalofPublicHealth.1999;89(9):1322-1327.

23. MelnykBM,Morrison-BeedyD.InterventionResearch:Designing,conducting,analyzing,andfunding.NewYork,NY:SpringerPublishingCompany;2012.

24. LeonAC,DavisLL,KraemerHC.Theroleandinterpretationofpilotstudiesinclinicalresearch.JPsychiatrRes.2011;45(5):626-629.

25. AnesthesiologistsASo.ASAPhysicalStatusClassificationSystem.2015.AccessedMarch21,2016.

26. HarrisPA,TaylorR,ThielkeR,PayneJ,GonzalezN,CondeJG.Researchelectronicdatacapture(REDCap)--ametadata-drivenmethodologyandworkflowprocessforprovidingtranslationalresearchinformaticssupport.JBiomedInform.2009;42(2):377-381.

27. IBMSPSSStatisticsforMAC,Version22.0[computerprogram].Armonk,NY:IBMCorp.;Released2013.

28. PreventionCfDCa.DivisionofNutrition,PhysicalActivity,andObesity,NationalCenterforChronicDiseasePreventionandHealthPromotion.2015;http://www.cdc.gov/healthyweight/assessing/bmi/adult.AccessedMarch18,2016.

29. MarsegliaL,MantiS,D'AngeloG,etal.Oxidativestressinobesity:acriticalcomponentinhumandiseases.IntJMolSci.2015;16(1):378-400.

30. KasenS,CohenP,ChenH,MustA.Obesityandpsychopathologyinwomen:athreedecadeprospectivestudy.IntJObes(Lond).2008;32(3):558-566.

31. LuppinoFS,deWitLM,BouvyPF,etal.Overweight,obesity,anddepression:asystematicreviewandmeta-analysisoflongitudinalstudies.ArchGenPsychiatry.2010;67(3):220-229.

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Table1.Demographicsoffemalebreastsurgeryparticipants

ParticipantCharacteristics(N=30) Mean±SDAge(years) 52.3±16.4BMI(kg/m2)* 29.1±6.9 Percent(%)Race White(n=20) 66.7BlackorAfricanAmerican(n=8) 26.7Asian(n=2) 6.7 Ethnicity NotHispanicorLatino(n=29) 96.7HispanicorLatino(n=1) 3.3 Diagnosis Malignantneoplasm,breast(n=14) 46.7Benignneoplasm,breast(n=1) 3.3Other(n=15) 50 MaritalStatus Married(n=17) 56.7Notmarried(n=8) 26.7Divorced(n=5) 16.7 NumberofChildren 0–2(n=21) 69.93–4(n=8) 26.7>5(n=1) 3.3 ASAPhysicalStatusClassification25 I(n=2) 6.7II(n=21) 70III(n=7) 23.3 SmokingStatus NeverSmoked(n=20) 66.7CurrentSmoker(n=4) 13.3QuitSmoking>1year(n=6) 20

*BMI=BodyMassIndex25=AmericanSocietyofAnesthesiologistphysicalstatusclassification.I=healthypatient;II=mild,well-controlledsystemicdisease;III=severesystemicdisease.

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Table2.RE-AIMdimensionsforevaluatingfeasibility

RE-AIM

Dimension

Definition AssessmentMeasures Results Comments

Reach Thenumberofindividualswhoarewillingtoparticipateinthestudy.

Recruitment–thenumberofparticipantsthatenrolleddividedbythenumberthatwereaskedtoparticipate.Attrition–thenumberofparticipantsretainedinthestudy.

Recruitment:30participantsenrolled/34approached=88.2%Attrition:1participantwithdrewinthepreoperativeperiod(3%)and8participantsdidnotcompletethepost-studyphonecall(26.7%).

Effectiveness Theimpactoftheintervention.

Duringthefollowupphonecall,participantswereaskedtorateiftheybelievedthepatchwashelpfulusingascalefrom0to5(0=nothelpfulatalland5=extremelyhelpful).

Ratings(N=22):0=9.1%(n=2)1=0%2=9.1%(n=2)3=13.6%(n=3)4=13.6%(n=3)5=54.5%(n=12)

Awelcomeddistraction,veryimpressed,Ilikedhavingtheoption,veryrelaxing,enjoyedthescent,soothing,Ibelieveinlavender,andthedoctorloveditaswell.

Adoption Thenumberofindividualswhoarewillingtoinitiatetheprotocol.

Duringthefollowupphonecall,participantswereaskedtoratetheirlikelinesstoparticipateinanaromatherapystudyinthefutureusingascalefrom0to5(0=notlikelyatalland5=extremelylikely).Duringthepost-studysurvey,providerswereaskedtoratehowlikelytheywouldbetoadopttheuseofaVASforanxietyassessmentinthepreoperativeperiodandhowlikelytheywouldbetouseanaromatherapypatchforpatient’sexperiencingacutepreoperative

Ratings(N=22):0=9.1%(n=2)1=0%2=0%3=9.1%(n=2)4=0%5=81.8%(n=18)Ratings(N=10):VAS0=40%(n=4)1=10%(n=1)2=20%(n=2)3=20%(n=2)4=0%5=10%(n=1)Patch0=0%1=10%(n=1)

Ithinkitshouldbeanoption,lovetoo,positiveexperience,mostdefinitely,Ifeelgreat.Iwouldratherverbalizethe1-10scale;Iwouldlikelyoftenforgetthistool.Participantstated:it(theVAS)didletmeknowthattheclosertime(tosurgery),I

75

anxietyonascalefrom0to5(0=notlikelyatalland5=extremelylikely)

2=20%(n=2)3=20%(n=2)4=20%(n=2)5=30%(n=3)

wasgettinganxiousandIwasabletotellsomebody.Iusuallykeepthattomyself.

Implementation Theassessmentanduseoftheprotocol.

Duringthefollowupphonecall,participantswereaskediftheyhadanyrecommendationforthestudy.Duringthepost-studysurveyproviders,wereaskediftheidentifiedanyproblemswithimplementationofthestudyprotocol,iftheyhadanyrecommendationforthestudy,andiftherewereanyproblemswithpatchplacementorremoval.

Answers(N=22):Yes=40.9(n=9)No=59.1%(n=13)Protocol(N=10):Yes=20%(n=2)No=80%(n=8)Recommendations:Yes:10%(n=1)No:90%(n=9)PatchPlacement/Removal:Yes:0%No:100%(n=10)

Alongeraromatherapypatchtime,notenoughpreoperativetimetogetthefullbenefitofthetherapy,additionofotheraesthetics(i.e.,lighting,music,additionalaromas,etc.)inthepreoperativesetting,participantsenjoyedhavingtheoption,choiceofsite,otherthanthechest,forpatchplacement,andaftersurgerywouldbeanicetimeforittoo.

Maintenance Theextenttowhichtheprotocolmaybecomeapartofroutinepractice.

Duringthefollowupphonecall,participantswereaskedtoratehowhelpfultheyfoundthepatchona0to5scale(0=nothelpfulatalland5=extremelyhelpful)andtodescribethescentofthepatchasmild,moderateorstrong.Duringthepost-study

Ratings(N=22):0=9.1%(n=2)1=0%2=9.1%(n=2)3=13.6%(n=3)4=13.6%(n=3)5=54.5%(n=12)Scent:Mild=22.7%(n=5)Moderate=54.5%(n=12)Strong=22.7%(n=5)Ratings(N=10):

Scent:Smellsgood,itwasperfect,Ilikedthelavender–commonlyusedinspassoourbrainmakesthatconnections,strongforthefirstcoupleofminutebutafterthatitwasperfect,notafanoflavender,

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survey,providerswereaskedtoratehowlikelytheywouldbetouseanaromatherapypatchforpatient’sexperiencingacutepreoperativeanxietyonascalefrom0to5(0=notlikelyatalland5=extremelylikely)andtodescribethescentofthepatchasmild,moderateorstrong.

0=0%1=10%(n=1)2=20%(n=2)3=20%(n=2)4=20%(n=2)5=30%(n=3)Scent:Mild=50%(n=5)Moderate=30%(n=3)Strong=20%(n=2)

foundittobetrulyrelaxing,overpowering,itdidn’tjustblendin–Icouldfocusonit.

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Table3.ComparisonusingpairedsamplestestforbaselineandfinalVAS,HR,andMAPmeasurements

Baseline Final Change Measurements Mean±StD

(95%CI)Mean±StD(95%CI)

Mean±StD(95%CI)

p-value

(t[df])VAS(cm) 5.7±2.6

(4.7;6.6)4.2±3.3(3.0;5.5)

1.4±3.4(0.15;2.7)

0.030(2.3[29])

HR(bpm) 76.1±12.9

(71.3;80.9)76.0±12.0(71.4;80.4)

0.17±9.2(-3.3;3.6)

0.922(0.1[29])

MAP(mmHg) 87.1±13.7

(82.0;92.2)84.5±12.3(79.9;89.1)

2.6±9.2(-0.85;6.0)

0.134(1.5[29])

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APPENDIX1.ParticipantFollowUpPhoneCallQuestionnaire

1. Onascalefrom0to5(0=nothelpfulatalland5=extremelyhelpful),howhelpfuldidyoufindthepatch?

Comments:2. Wouldyoudescribethescentofthepatchasmild,moderate,orstrong?

a. Mildb. Moderatec. Strong

Comments:3. Doyouhaveanyrecommendationsforthestudy?

a. Yesb. No

Comments:4. Onascalefrom0to5(0=notlikelyatalland5=extremelylikely),howlikely

wouldyoubetoparticipateinanaromatherapystudyinthefuture?Comments:

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APPENDIX2.ProviderREDCapPost-StudySurvey

1. Onascalefrom0to5(0=notlikelyatall)and5=extremelylikely),howlikelywouldyoubetoadopttheuseofaVisualAnalogScale(VAS)foranxietyassessmentinthepreoperativeperiod?

Comments:2. Onascalefrom0to5(0=notlikelyatall)and5=extremelylikely),howlikely

wouldyoubetouseanaromatherapypatchforpatient’sexperiencingacutepreoperativeanxiety?

Comments:3. Didyouidentifyanyproblemswithimplementationofthestudyprotocol?

a. Yesb. No

Comments:4. Doyouhaveanyrecommendationstoimprovetheprocessorprotocol

implementation?a. Yesb. No

Comments:5. Werethereanyproblemswithpatchplacementand/orpatchremoval?

a. Yesb. No

Comments:6. Wouldyoudescribethescentofthepatchasmild,moderate,orstrong?

a. Mildb. Moderatec. Strong

Comments:

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Appendix3.10-cmVisualAnalogScaleforAnxietyLevelAssessment(nottoscale)

Time:&__________&

Using&a&ver/cal&line,&please&mark&your&&current&level&of&anxiety&on&the&scale&

no&anxiety&=&0& 10&=&extreme&anxiety&

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Conclusion

Thisdissertationexploredtheconceptofrelieffromanxietyusingcomplementary

therapiesinmanuscriptone.Reliefwasfoundtobeadynamicconceptandrelieffrom

anxietyiscriticalinhealthcare.Careguidedbyanabilitytoassessanxietyasaunique

entityisessentialforsurgicalpatientstoensuretheirhealth,healingandwellbeing.Thus,

furtherresearchtoaccuratelydefinereliefaswellasmeasurerelieffromanxietyisafuture

goal.

Inthesecondmanuscriptofthisdissertation,instrumentsusedtomeasureanxiety

levelsandtheirpsychometricpropertieswereexplored.Unfortunately,onlyafew

instrumentsexistthatspecificallymeasureacutepreoperativeanxietyforsurgicalpatients.

TheVASappearedtoprovidetheeasiesttouseandmostefficientmeasureinthe

preoperativeperiod;however,reliabilityandvaliditywerenotconsistentlyreportedforall

theinstrumentsreviewed.ThisshouldraiseconcernsforproviderswhowishtouseaVAS,

theSTAI,theSAI,ortheASSQtomeasurepreoperationalanxietyandprovidetreatment

basedontheinstruments’results.Furtherresearchisneededtodesignandimplementa

practicalinstrumentwithhighsensitivityandspecificitytomeasureanxietyinthe


Buildingontheconclusionsofmanuscriptsoneandtwo,astudywasdesignedand

conductedtoevaluatethefeasibilityofrecruitment,retention,adherence,andadoptionofa

sustained-releaselavenderaromatherapypatchappliedtothechestandtheuseofaVASto

measureanxietylevelsduringthepreoperativeperiodamongfemalepatientsscheduled

forbreastsurgery.Theresultsofthestudyindicatethataromatherapyisafeasibleand

potentiallyefficaciousinterventiontoreduceanxietyasmeasuredbyaVASinthe

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preoperativeperiod.Therecruitmentapproachwashighlyfeasibleandacceptableto

patientsandadherenceandadoptionoftheprotocolwasfeasibleandincorporatedwith

easebythepreoperativeproviders.Asalogicalnextstep,anadequatelypowered

randomizedcontrolledtrialisneededtodeterminetheefficacyofasustained-release

aromatherapypatchonpreoperativeanxietyandthebestapproachtomeasurebio-

behavioraloutcomes.

LessonsLearnedandNextSteps

Severallimitationsweresubstantiatedbythisdissertation.First,littleisknown

aboutthe“best”methodstoassess,measureandtreatacutesituationalanxietyinthe

preoperativeperiod.Thislimitationledtoafeasibilitystudyratherthanarandomized

controlledstudytofirstdeterminewhethertheapproachwassoundandacceptableto

patientsandproviders,thusassessingimplementationprocesseswasthefirststep.Second,

aconveniencesampleoffemalepatients,fromonepreoperativelocationinalarge

quaternarymedicalcenter,scheduledforbreastsurgerywasrecruitedforthisstudy.These

restrictionsonsampling,locationandsurgicalprocedurewilllimitthegeneralizabilityof

findings.Third,theuseofbiomarkersofstresssuchascortisol,epinephrine,and

norepinephrinelevelsoradditionalphysiologicalsignssuchasrespiratoryrate,

perspirationandheartratevariabilitycouldhaveprovidedmoresensitiveindicatorsof

anxiety.Lastly,onlyonescent,lavender,wasavailabletopatients.Thisscentmaynot

appealtoeveryone;achoiceofscentsmayhaveprovidedmorepositiveoutcomeson

preliminarysignalsofefficacy,forexample,onheartrateandbloodpressurereductions.

Despitetheselimitations,thisdissertationcontributestothecurrentbodyofknowledgeon

theconceptofrelief,instrumentstomeasureacutesituationalanxiety,andthefeasibilityof

83

recruitment,adoption,andimplementationofanaromatherapyinterventionforanxietyin

thepreoperativeperiod.Thepotentialhealthimplicationsforthefieldofsymptomscience

arenumerous.

Anumberofvaluablelessonswerelearnedabouttheresearchprocessfrommy

interactionswithmembersoftheProtocolReviewCommitteeandtheInstitutionalReview

Boardandtheirprocessestocreatingandutilizinganelectronicdatabaseand

opportunitiestoworkwithwritingexperts.Additionally,thetimeIspentinthe

preoperativearearecruitingandmonitoringparticipantsallowedmetobetterunderstand

thepreoperativeenvironment,haveabetterrelationshipwiththepreoperativenurses,and

seefirsthandwhatthepreoperativeexperienceoverallislikeforpatients.Asforthenext

steps,ourinterprofessionalteamofpreoperativenurses,anesthesiaprovidersand

surgeonsiswellpositionedtocontinueworkinthisareaincludingafuturerandomized

controlledtrial.Theplanistobuildonfindingsfromthisfeasibilitystudytowardagrant

applicationthroughtheNationalInstituteofNursingResearchtodeterminetheefficacyof

anaromatherapypatchcomparedtoaplacebopatchonpreoperativeanxietyamong

patientsundergoingavarietyofsurgicalprocedures.Thestudywillexplicatea

measurementmodelthatincludesbio-behavioraloutcomesforamoredefinitivestudyof

thesymptomsofanxiety.Thelong-termobjectivewouldbetoofferpatientsundergoing

operativeandnon-operativeprocedurestheopportunitytoself-manageanxietythrough

theuseofaromatherapy.

84

Appendices

85

December 11, 2015 Candace Jaruzel, MSN, CRNA Instructor Department of College of Health Professions/ Anesthesia for Nurses Medical University of South Carolina Charleston, SC, 29425 Dear Ms. Jaruzel: At the December 11, 2015 meeting of the Protocol Review Committee (PRC), your research protocol entitled “Aromatherapy for Preoperative Anxiety for Female Patients Undergoing Breast Surgery: A Feasibility Study” (CTO #: 102425/Sponsor: MUSC; protocol version December 10, 2015) was approved as written for use at Hollings Cancer Center. As required by the NCI for all Designated Cancer Centers awarded a Cancer Center Support Grant (CCSG), MUSC-HCC must report all oncology clinical trial activity occurring at MUSC. Because the abovementioned study has qualified for PRC review and approval, this study is subject to ongoing reporting requirements to the PRC to ensure compliance to CCSG standards. As Principal Investigator, it is your responsibility to ensure the following information is submitted to the HCC PRC at [email protected]. Please make sure that CTO#102425 is listed in any email correspondence. 1) MUSC IRB Initial Approval Letter and Date of Study Activation Please note that consideration for approval of this study by the MUSC IRB is pending. The MUSC IRB will require the provision of a PRC approval letter within your IRB application. Once a study is IRB approved, please submit the IRB approval letter to the PRC. If the study does not receive IRB approval and the study is withdrawn, please contact the PRC of this status. Study Activation is defined as the time when the study is eligible to begin enrollment to the trial. When the study is activated, please provide the PRC this activation date. 2) All Significant Protocol Amendments require PRC approval Significant Protocol changes are defined as changes in any of the following: a) Study objectives, b) Research plan or study design, c) Eligibility, d) Statistical Consideration, e) Patient population and/or accrual figures. Any significant change requires PRC approval prior to IRB submission. It is required that a marked document and/or detailed summary of changes and the PRC Amendment Form be provided to the PRC. The PRC form is located at http://hcc.musc.edu/intranet/prms/protocolcommittee.htm The PRC Chair will initially review the documents and may approve under expedited review. Should there be additional concerns, the PRC chair has the authority to request full board review of the amendment. 2) Monthly Accrual Updates and Biannual Accrual Review

86

On a monthly basis, it is required that updated accrual information is provided. A copy of the accrual log form is located on the HCC PRC website at http://hcc.musc.edu/intranet/prms/protocolcommittee.htm In addition, PRC conducts a biannual trial performance review in which the level of accrual is reviewed. Should your predicted accrual period or accrual estimate change from your initial form submission, please contact the PRC. 3) Changes in Study Status When the study is closed to accrual or terminated, it is required that the PRC be notified of the status change. Any applicable IRB letter regarding this change in status should be provided. Conducting research is a critical component of our University’s mission. Thank you for your efforts and should you have any questions regarding PRC, please feel free to contact the PRC chairs or administrator. Sincerely, James Ravenel, MD Co-Chair, Protocol Review Committee cc: CTO Binder #102425

87

InstitutionalReviewBoardforHumanResearch(IRB)

OfficeofResearchIntegrity(ORI)

MedicalUniversityofSouthCarolina

HarborviewOfficeTower

19HagoodAve.,Suite601,MSC857

Charleston,SC29425-8570

FederalWideAssurance#1888

APPROVAL:

ThisistocertifythattheresearchproposalPro00049642entitled:Aromatherapyforpreoperativeanxietyforfemalepatientsundergoingbreastsurgery:Afeasibility

study

submittedby:CandaceJaruzel,CRNA,MSN Department:HEALTHPROFESSIONSRESEARCHDIVISION-MUSC ProtocolVersion:6 Dated:12/10/2015forconsiderationhasbeenreviewedbyIRB-I-MedicalUniversityofSouthCarolinaandapprovedwithrespecttothestudyofhumansubjectsasadequatelyprotectingtherightsandwelfareoftheindividualsinvolved,employingadequatemethodsofsecuringinformedconsentfromtheseindividualsandnotinvolvingundueriskinthelightofpotentialbenefitstobederivedtherefrom.NoIRBmemberwhohasaconflictinginterestwasinvolvedintherevieworapprovalofthisstudy,excepttoprovideinformationasrequestedbytheIRB.OriginalApprovalDate:1/5/2016ApprovalExpiration:1/4/2017Type:FullIRBReviewViceChair,IRB-I-MedicalUniversityofSouthCarolinaSusanNewman∗StatementofPrincipalInvestigator:Aspreviouslysignedandcertified,Iunderstandthatapprovalofthisresearchinvolvinghumansubjectsiscontingentuponmyagreement:

1. To report to the Institutional Review Board for Human Research (IRB) any adverse events orresearchrelatedinjurieswhichmightoccurinrelationtothehumanresearch.IhavereadandwillcomplywithIRBreportingrequirementsforadverseevents.

2. TosubmitinwritingforpriorIRBapprovalanyalterationstotheplanofhumanresearch.3. TosubmittimelycontinuingreviewreportsofthisresearchasrequestedbytheIRB.4. To maintain copies of all pertinent information related to the research activities in this project,

includingcopiesofinformedconsentagreementsobtainedfromallparticipants.5. To notify the IRB immediately upon the termination of this project, and/or the departure of the

principalinvestigatorfromthisInstitutionandtheproject.

∗ElectronicSignature:ThisdocumenthasbeenelectronicallysignedbytheIRBChairmanthroughtheHSSCeIRBSubmissionSystemauthorizingIRBapprovalforthisstudyasdescribedinthisletter.

aromatherapy for preoperative anxiety among female breast

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