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Quality Improvement Project tou

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distraction and a benzocaine-based anesthetic spray. The original protocol is used at a large, university-based pediatric primary care hospital. A convenience sample of 30 children from a community-based

to increase on-timen perceived pain orely return for futureipher, 2013, p. 352).ique utilized during

to be a method of choice for pediatric patients. Providingappropriate distraction creates the potential to reduce theE-mail addresses: [email protected]

http://dx.doi.org/10.1016/j.pedn.2014.09.002882-5963/ 2015 Elsevier Inc. All rights reserved.

Journal of Pediatric Nursing (2015) 30, 29430002 The paper has not previously been presented. Corresponding author: Stephanie Burgess, DNP.painful and distressing situations. In existing studiescomparing stress reduction techniques, distraction appears

1 No extramural funding or commercial financial support has beenutilized in this study.have been 1 of several factors in the 2010 California pertussisresurgence (p. 624). The Centers for Disease Control andPrevention currently recommends children to be vaccinatedagainst sixteen different illnesses. Most vaccinations are

distressing immunization experiencesvaccination. Furthermore, a reduction ianxiety by the parent may promote timvaccinations (Luthy, Beckstrand, & Puls

Stress reduction is a common technUnder immunization of children has become moreprominent in the United States as more parents are followingalternative vaccination schedules or refusing vaccinations alltogether. Evidence has linked vaccine refusal with outbreaksof vaccine preventable diseases (Omer, Salmon, Orenstein,deHart, & Halsey, 2009). A study by Atwell et al. (2013),further suggests clusters of unvaccinated individuals may

injections by age 6 years (CDC, 2014). The immunizationprotocol utilized by a primary care office can greatly impactthe overall immunization experience. Stockwell, Irigoyen,Martinez, and Findley (2011) discovered an associationbetween previous negative immunization experiences andunder immunization in children. These findings imply thatchildhood experiences with immunizations have the potentialto impact the incidence of vaccine preventable diseases.Therefore, steps should be taken to decrease painful andackgroundhealthcare center was utilized to assess effectiveness in alternate settings. This quasi-experimentalproject collected survey information from child participants and consenting caregivers. Statisticalanalysis by paired t-test indicated a statistically significant decrease in reported distress by both the childand the caregiver utilizing the immunization protocol. 2015 Elsevier Inc. All rights reserved.

B given as multi-dose series resulting in as many as 33Distress Associated With ImmPediatric Primary Care1,2

Stephanie Burgess, DNP, Donna G. NativJoyce E. Penrose, DrPH, CRNP, FNP-BC

University of Pittsburgh School of Nursing, Pittsburgh, PA

Received 10 May 2014; revised 2 September 2014; accepted 5 Sep

Key words:Distraction;

This quality improvement prodecreasing pain and distressReduce Pain andnization Visits in

PhD, CRNP, FAAN,

er 2014

implemented an evidence-based immunization protocol aimed atiated with immunizations for children ages 4 to 6 by utilizing

at decreasing pain and distress. To help lessen thoseaforementioned barriers to meeting recommended immuni-

295295TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATIONzation rates, an evidence-based immunization protocoldeveloped for and still in use at a large, university basedpediatric primary care hospital was utilized. The goal of thisproject was to decrease pain and distress for both the patientand the accompanying caregiver by implementing animmunization protocol utilizing an active physical distracterand a benzocaine-based anesthetic spray with immunizationsvisits in an urban, community-based, primary care center.

Methods

Setting

This quality improvement project, guided by the Reisand Holubkov (1997) study findings, was completed in asmall, urban, community-based health care center situatedin a medically underserved neighborhood. The majority ofpatients have government funded insurance and benefitfrom the Vaccines for Children program where theyreceive vaccines at no cost. The pediatrician in the centerhas been serving this community for nearly 25 years, thenurse practitioner and medical assistant have been there1 year and the registered nurses have each provided2 years of service.

Human Subject Protection

The University of Pittsburgh Institutional Review Boardconsidered this project to be exempt. Written consent wasobtained from the caregivers of the participating patients.overall distress exhibited by the patients as well as theircaregiver (Manne, Redd, Jacobsen, Gorfinkle, & Schorr,1990). Manne et al. (1990) used party blowers as a means ofdistraction in children aged 3 to 9 years undergoingvenipuncture while other studies have used touch screenelectronic toys and virtual reality glasses. Reis and Holubkov(1997) studied the utilization of a.) distraction alone versusb.) distraction combined with a vapocoolant spray and c.)distraction combined with an eutectic mixture of localanesthetics (EMLA) cream during immunization procedures.Their findings indicate that using a method of distractioncombined with the use of a vapocoolant spray is an effective,fast and inexpensive way to reduce the pain and distressassociated with immunizations.

Immunizations are a recommended and beneficialprocedure. Rarely are steps taken to decrease the associatedpain and distress despite available evidence-based protocolsdue to time constraints (Weissenstein, Straeter, Villalon,Luchter, & Bittmann, 2013). Pain and distress are knownbarriers to meeting recommended immunization rates. Thehealth care center where this project was implemented hadnot been using a standard protocol for immunizations aimedStaff Education

To educate the staff in preparation for participating in thisproject, a lecture focusing on the importance of pain anddistress reduction to aid immunization compliance andtimeliness was provided to the two registered nurses, a nursepractitioner and a medical assistant. The project protocol wasdescribed, and the staff's role and participation was discussed.They were allowed to practice with the materials, and theirquestions were addressed.

Intervention

All children aged 4 to 6 years, receiving at least oneimmunization were eligible to participate unless there was aknown sensitivity to benzocaine. Once a patient in theappropriate age range was identified on the schedule, a chartreview was completed, prior to their scheduled appointment,to identify any known allergy or sensitivity to benzocaine.The patient/caregiver dyads were approached in their examroom after their immunizations were ordered by the MD orNP to assess their willingness and ability to participate in theproject. A script was utilized to explain the project to thedyad. If they agreed to participate, a consent form, written ata fifth grade reading level, was signed and kept on file. Acopy was provided to the signer.

After consent was gained, the dyad was instructed on howto fill out the short pre-immunization survey consisting ofthree questions which were read to the caregiver by the firstauthor (see Box A). Before immunization, all children, wereprovided with a party blower as a distraction and instructedto blow it at the RN's, MA's or caregiver's moving hand, asif it were a target, during the procedure. Practice blowing wasencouraged prior to the immunization.

The staff administering the injection sprayed the injectionsite with the benzocaine-based cooling spray for 5 to10 seconds at least 3 inches away from the skin, waited 20to 30 seconds, cleaned the site with alcohol and administeredthe injection per manufacturer's recommended route whilefacilitating the party blower use.

Following immunization, the caregiver completed the post-immunization survey consisting of three questions, nearlyidentical to the pretest, which were also read to the caregiver(see Box B). A cover sheet identifying the child's age, sex,reason for visit, accompanying caregiver, additional members inthe room, immunization(s) received and who administered theimmunization was completed, and all data forms were placed ina manila envelope to promote organization and confidentialityand were kept in a locked file box to await analysis.

Data Collection

Prior to immunization, the first author collected historicaldata from the accompanying caregiver utilizing VisualAnalog Scales (VASs). These scales have been found to be

eliable tools to assign number values to typically subjectiveata such as pain and distress with an intraclass correlationoefficient of 0.97 [95% CI = 0.96 to 0.98] (Bijur, Silver, &allagher, 2001). VASs are horizontal lines exactly 100 mmlength with a descriptor phrase on each end of the line. Theescriptors are typically opposite ends of a spectrum such asnot at all upset and extremely upset and, therefore, createcontinuum of possible answers. The individual being

ssessed marks a vertical line somewhere on the continuumf the VAS which they feel best describes how they feel.his mark is then measured, in mm, from the left margin, toumerically describe their answer.The caregivers were asked to identify the typical level of

istress expressed by the child as well as the typical level ofistress they experience as the observing caregiver byarking a line on sliding scale labeled with descriptorsrom not at all upset to extremely upset. Followingmunization, utilizing a VAS with the aforementioned

liding scale, the caregiver was asked to identify the level ofistress expressed by the child as well as the level of distressey experienced during the current immunization.Additionally, pre- and post-immunization data on painere collected by the first author directly from the childtilizing the Wong-Baker FACES Pain Rating Scale to

quantify any change in pain rating associated with theimmunization procedure. The Wong-Baker FACES PainRating Scale is a widely utilized measurement tool whichallows children to effectively describe the pain they arefeeling. This scale has been found to be both reliable, with astatistically significant testretest reliability of r = .83, andvalid, with a statistically significant concurrent validity whencompared to both a word graphic scale (r = .63) and anumerical scale (r = .75), for the age range being assessedin the project (Keck, Gerkensmeyer, Joyce, & Schade, 1996)Furthermore, in a study by Wong and Baker (1988comparing six separate pain assessment scales, the FACESPain Rating Scale scored the highest preference in childrenages 3 to 7 years. The scale consists of a series of six facewith increasing levels of discomfort displayed on them. Achild is to select the face which best illustrates how they feelEach face has an associated number which allows their painto be numerically described.

A cover sheet identifying the child's age, sex, reason fovisit, accompanying caregiver, additional members in theroom, immunization(s) received and who administered theimmunization was completed by the first author.

Following the completion of data collection, the RNs andMA participating in the administration of immunization

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Box A Pre-immunization ratings.

296 S. Burgess et al.rdcGindaaoTn

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wuPre-Immun

1.) Please mark a line to indicate how upset you

Not At AllUpset

2.) Please mark a line to indicate how upset you

Not At AllUpset

3.) Please help your child circle the face which b.)

s

.

r

stion Ratings

d was after the last immunization they received.

ExtremelyUpset

after the last immunization your child received.

ExtremelyUpset

ows how they are currently feeling.

ere given a Likert scale survey to assess the feasibility of therotocol which was created by the first author (see Box C). Onis Likert scale, the answer choices ranged from 1: stronglyisagree to 5: strongly agree. They were asked to respond toe following statements, a.) Our current method of immuni-ation for children, ages 4 to 6, works well in our setting. b.) Imwilling to try anothermethod to improve the outcome for thehild and caregiver. c.) A method of immunization usingistraction and a benzocaine-based vapocoolant spray has theotential to improve our immunization procedure. d.) I amkely to continue to use an immunization procedure usingistraction and benzocaine-based vapocoolant spray in theture. and e.) I think it is realistic to continue to use thismunization procedure in our setting.

ata Analysis

Data were analyzed utilizing SPSS version 19. The pre-nd post-immunization data from the VAS and the Wong-aker FACES Pain Rating Scale underwent paired t-testnalysis. The feasibility data from the staff was analyzed foreasures of central tendency.

Results

Recruitment took place from September to mid-October2013. During that time, a total of 30 dyads were approachedfor involvement in this project, and all 30 agreed toparticipate. They are described in Table 1. Of the 30participants, 50% were age 4, 26.6% were age 5 and 23.3%were age 6. With 12 males and 18 females, the majoritywere present with their mother (80%) while others presentedwith their father (6.6%), grandmother (6.6%), mother &father (3.3%), and foster mother (3.3%). Eighteen presentedfor an annual well child visit, 7 for an acute visit, and 5 forother visits.

As for the number of vaccinations received, 60% receiveda single vaccination, 10% received two, 3.3% received three,20% received four, and 6.6% received five vaccinations.There were no additional family members in the room for40% of the dyads, another 40% had one additional familymember, 16.6% had two additional family members and3.3% had three additional family members in the room.

Table 2 summarizes the pre- and post-interventiondata for all participating dyads. Age, sex and number of

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u we

best s

Box B Post-immunization ratings.

297297TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATIONwpthdthzacdplidfuim

D

aBamPost-Immu

1.) Please mark a line to indicate how upset yo

Not At AllUpset

2.) Please mark a line to indicate how upset yo

Not At AllUpset

3.) Please help your child circle the face which ation Ratings

ild was after todays immunizations.

ExtremelyUpset

re after your childs immunizations today.

ExtremelyUpset

hows how they are currently feeling.

munizations have also been listed in the table to aidcomparison.The staff participating in the administration of the

realistic to continue to use this immunization procedure inour setting., the average response was 4.67.

The paired-t test analysis of the pre- and post-interventionchild distress ratings produced a t = 2.985 with a 2-tailedsignificance of p = .006 (Table 4). This indicates astatistically significant decrease in the child's reporteddistress following an immunization procedure which utilizeddistraction and a benzocaine-based anesthetic spray ascompared to an immunization procedure which did notutilize distraction and a benzocaine-based anesthetic spray.

The paired-t test analysis of the pre- and post-interventioncaregiver distress ratings produces a t = 3.226 with a 2-tailedsignificance of p = .003. This also indicates a statisticallysignificant decrease in the caregiver's reported distressfollowing an immunization procedure which utilized distrac-tion and a benzocaine-based anesthetic spray as compared toan immunization procedure which did not utilize distractionand a benzocaine-based anesthetic spray.

For the paired-t test analysis of the pre- and post-intervention pain ratings, a t = .348 with a 2-tailedsignificance of p = .730 was found. This indicates thatthere was not a statistically significant increase in the

n (%)

Age 4 15 (50)5 8 (26.7)6 7 (23.3)

Sex Male 12 (40)Female 18 (60)

Accompanying caregiver Mother 24 (80)Father 2 (6.7)Grandmother 2 (6.7)Mother & father 1 (3.3)Foster mother 1 (3.3)

Type of visit Annual well child 18 (60)Acute visit 7 (23.3)Other 5 (16.7)

Vaccinations received 1 18 (60)2 3 (10)3 1 (3.3)4 6 (20)5 2 (6.7)

Additional familymembers in room

0 12 (40)1 12 (40)2 5 (16.7)3 1 (3.3)

1.) Our current method of immunization for children, ages 4 to 6

1 2 3Strongly Disagree Disagree Neut

2.) I am willing to try another method to improve the outcome fo


3.) A method of immunization using distraction and a benzocainour immunization procedure.


4.) I am likely to continue to use an immunization procedure usin the future.


5.) I think it is realistic to continue to use this immunization proc


Box C Feasibi

298 S. Burgess et al.immunizations were given the five question Likert scalefeasibility survey previously described. The findings aresummarized in Table 3. For the first question, Our currentmethod of immunization for children, ages 4 to 6, works well

Table 1 Demographics.iminin our setting., the average response was 3.67. The secondquestion, I am willing to try another method to improve theoutcome for the child and caregiver., had an averageresponse of 4. The third question, A method of immuni-zation using distraction and a benzocaine-based vapocoolantspray has the potential to improve our immunizationprocedure., had an average response of 4.67 while thefourth question, I am likely to continue to use animmunization procedure using distraction and benzocaine-based vapocoolant spray in the future., had an averageresponse of 4.67. Finally, for the fifth question, I think it is

, works well in our setting.

4 5ral Agree Strongly Agree

r the child and caregiver.


e-based vapocoolant spray has the potential to improve


ing distraction and benzocaine-based vapocoolant spray


edure in our setting.


lity survey.

Table 2 Pre- and post-intervention data.

Age Sex Number ofimmunizationsreceived

Caregiver's estimation ofchild's response

Caregiver's response Child's pain rating

Pre-interventiondistress rating

Post-interventiondistress rating

Pre-interventiondistress rating

Post-interventiondistress rating

Pre- interventionpain rating

Post-interventionpain rating

1 5 F 4 55 24 4 2 6 02 5 F 1 53 7 9 2 0 03 4 M 1 57 5 82 9 0 04 4 F 1 73 18 84 7 0 05 4 F 1 36 10 78 17 0 06 4 M 4 100 51 20 0 2 67 4 F 4 21 11 60 8 2 08 6 M 1 12 8 14 13 4 09 5 M 1 10 9 12 12 0 010 4 M 4 40 97 67 87 8 1011 5 M 1 52 0 012 5 M 1 100 0 0

5680

299299TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATION13 6 F 1 25 3814 4 F 5 68 9215 4 F 4 70 9416 5 F 1 43 0reported level of pain for the child before the immunizationprocedure as compared to the reported level of pain afterthe procedure.

Table 3 Feasibility survey responses.

Question Averageresponse

Our current method of immunization for children,ages 4 to 6, works well in our setting.

3.67

I am willing to try another method to improve theoutcome for the child and caregiver.

4

A method of immunization using distraction and abenzocaine-based vapocoolant spray has thepotential to improve our immunization procedure.

4.67

I am likely to continue to use an immunizationprocedure using distraction and benzocaine-basedvapocoolant spray in the future.

4.67

I think it is realistic to continue to use thisimmunization procedure in our setting.

4.67

17 4 F 2 79 90 718 6 F 1 78 66 619 6 M 1 0 0 020 4 F 1 0 0 121 4 M 5 29 35 322 4 M 2 0 16 023 4 M 2 52 26 524 4 F 4 100 54 125 4 F 3 100 75 726 6 F 1 8 12 927 6 F 1 8 15 928 5 M 1 79 38 529 6 F 1 100 74 530 5 F 1 45 0 0Mean 49.77 32.17 30 0 00 8 2

5 43 8 106 2 6

7 94 0 80 0 0The nursing staff indicated that they are likely to continueto use the immunization procedure with distraction and abenzocaine-based anesthetic spray. Furthermore, they alsobelieve that is it strongly realistic and feasible to do so intheir setting.

Table 4 Paired-t test data comparing pre- andpost-intervention data.

t df Significance(2-tailed)

Pre- vs. post-intervention childdistress rating

2.985 29 .006

Pre- vs. post-intervention caregiverdistress rating

3.226 29 .003

Pre- vs. post-intervention pain rating .348 29 .730 = Significant at p b 0.05.

9 44 0 64 50 2 4

0 2 000 55 0 22 20 0 4

0 0 20 30 8 600 31 0 49 79 10 0

13 4 014 2 03 4 2

1 50 0 100 2 0

8.53 22.97 2.47 2.73

Discussion

While there was no statistically significant change in pain

typically a painful, tearful experience, is an asset for thisprotocol. This finding coupled with the statistically significantdecrease in distress supports the utilization of this evidence-based immunization protocol to promote a limitation of painand a decrease in distress associated with immunizations forthis setting. All staff participating in this project supports

While the findings from this project could be attributed tothe novelty of the party blower and anesthetic spray, only

protocol is being utilized correctly. It will also need to beadopted into the new staff orientation process.

In the future, further study could evaluate the effectivenessof the protocol outside of the 4 to 6 year age range. It may bebeneficial to the overall protocol to have options of physicaldistractors for the child or caregiver to select which they likebest. This may improve the impact of the distractor and allowcaregivers to select a method which is appropriate for theirchild. Furthermore, it may prove beneficial to conductadditional studies to identify any significant impact that the

Wong, D., & Baker, C. (1988). Pain in children: Comparison of assessmentscales. Pediatric Nursing, 14, 917.

300 S. Burgess et al.further study would be able to ascertain this.

Conclusions

Finding an immunization procedure that not only garnersstaff buy-in but also produces statistically significant lessdistress for both the child and the caregiver is a positive steptoward promoting on-time immunization. If used consis-tently and properly, this immunization procedure has thepotential to decrease negative immunization experiences,increase on-time immunization and decrease the incidenceof vaccine preventable diseases.

If the health care center where this project was conductedadopts this protocol as their standard procedure, periodicmonitoring will need to be conducted to ensure that thethis protocol, and the patient population appears to supportthis protocol as well as all dyads approached for participa-tion in this project agreed to participate. The protocol is nottime consuming and is easily integrated into the staff'simmunization process.

As found in previous studies, distraction and, specifi-cally, party blowers work well as a method of limiting painand distress associated with painful procedures in thoseaged 4 to 6 years. Furthermore, despite using an alternativespray, this project supports Reis and Holubkov (1997)'sfindings which indicate using a method of distractioncombined with the use of a vapocoolant spray is aneffective, fast and inexpensive way to reduce the pain anddistress associated with immunizations.number of immunizations and even the number of individualsin the room may have on the child's level of pain and distress.

References

Atwell, J. E., Otterloo, J. V., Zipprich, J., Winter, K., Harriman, K., Salmon,D. A., et al. (2013). Nonmedical vaccine exemptions and pertussis inCalifornia, 2010. Pediatrics, 132, 624630.

Bijur, P. E., Silver, W., & Gallagher, J. (2001). Reliability of the visualanalog scale for measurement of acute pain. Academic EmergencyMedicine, 8, 11531157.

Centers for Disease Control and Prevention (2014). Birth 18 years &catch-up immunization schedules. Retrieved from. http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html.

Keck, J., Gerkensmeyer, J., Joyce, B., & Schade, J. (1996). Reliability andvalidity of the faces and word descriptor scales to measure proceduralpain. Journal of Pediatric Nursing, 11, 368374.

Luthy, K. E., Beckstrand, R. L., & Pulsipher, A. (2013). Evaluation ofmethods to relieve parental perceptions of vaccine-associated pain andanxiety in children: A pilot study. Journal of Pediatric Health Care, 27,351358.

Manne, S., Redd, W., Jacobsen, P., Gorfinkle, K., & Schorr, O. (1990).Behavioral intervention to reduce child and parent distress duringvenipunture. Journal of Consulting and Clinical Psychology, 58, 565572.

Omer, S., Salmon, D., Orenstein,W., deHart, P., &Halsey, N. (2009). Vaccinerefusal, mandatory immunization, and the risks of vaccine-preventablediseases. New England Journal of Medicine, 360, 19811988.

Reis, E., & Holubkov, R. (1997). Vapocoolant spray is equally effective asEMLA cream in reducing immunization pain in school-aged children.Pediatrics, 100, e5.

Stockwell, M., Irigoyen, M., Martinez, R., & Findley, S. (2011). How parentsnegative experiences at immunization visits affect child immunization statusin a community in New York City. Public Health Reports, 126, 2432.

Weissenstein, A., Straeter, A., Villalon, G., Luchter, E., & Bittmann, S.(2013). Reminder: How with little effort the vaccination of children canbe made less painful. Clinical Pediatrics, 52, 765766.rating, this is a clinically significant finding. Minimizing theamount of pain inflicted with immunizations, which are

Quality Improvement Project to Reduce Pain and Distress Associated With Immunization Visits in Pediatric Primary CareBackgroundMethodsSettingHuman Subject ProtectionStaff EducationInterventionData CollectionData Analysis

ResultsDiscussionConclusionsReferences

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