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JBI Database of Systematic Reviews & Implementation Reports 2013;11(7) 283-298 doi: 10.11124/jbisrir-2013-899 Page 283 The effectiveness of information-sharing interventions as a means to reduce anxiety in families waiting for surgical patients undergoing an elective surgical procedure: a systematic review protocol Judy Munday RN, DipEd (Nurs), BA (Hons), MSc(AppSci) candidate 1,2 Kathryn Kynoch RN, BN, MN (Intensive Care), PhD candidate 1,2 Sonia Hines, RN, BN, MAppSc (Research) 1 1 Nursing Research Centre; Mater Health Services; The Queensland Centre for Evidence-Based Nursing and Midwifery: a Collaborating Centre of the Joanna Briggs Institute 2 Queensland University of Technology, Kelvin Grove, Brisbane, Queensland, Australia Corresponding author: Judy Munday Email: [email protected] Review question/objective What are the most effective information sharing strategies used to reduce anxiety in families of patients undergoing elective surgery? This review seeks to synthesize the best available evidence in relation to the most effective information-sharing intervention to reduce anxiety for families waiting for patients undergoing an elective surgical procedure. The specific objectives are to review the effectiveness of evidence of interventions designed to reduce the anxiety of families waiting whilst their loved one undergoes a surgical intervention. A variety of interventions exist and include surgical nurse liaison services, intraoperative reporting either by face-to-face or telephone delivery, informational cards, visual information screens, and intraoperative paging devices for families. Background The provision of information, preoperative preparation and anxiety reduction for surgical patients has been the dominant focus in surgical care literature; however the care of the families of surgical patients also deserves attention. For the purpose of this systematic review, the term ‘family’ is defined as a self-defined group of individuals who derive support from each other. 1 Families most often provide the backbone of physical and emotional support for patients in the postoperative phase. This is increasingly the case as patients are now being discharged from hospital postoperatively ‘sooner and sicker.’ 2,p424 In addition, as surgical episodes increase across the world, more family members are experiencing

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Page 1: The effectiveness of information-sharing interventions as ... · doi: 10.11124/jbisrir-2013-899 Page 286 SLNs performing this role has been open to discussion. Post-anaesthetic care

JBI Database of Systematic Reviews & Implementation Reports 2013;11(7) 283-298

doi: 10.11124/jbisrir-2013-899 Page 283

The effectiveness of information-sharing interventions as a means to reduce anxiety in families waiting for surgical patients undergoing an elective surgical procedure: a systematic review protocol

Judy Munday RN, DipEd (Nurs), BA (Hons), MSc(AppSci) candidate1,2

Kathryn Kynoch RN, BN, MN (Intensive Care), PhD candidate1,2

Sonia Hines, RN, BN, MAppSc (Research) 1

1 Nursing Research Centre; Mater Health Services; The Queensland Centre for Evidence-Based

Nursing and Midwifery: a Collaborating Centre of the Joanna Briggs Institute

2 Queensland University of Technology, Kelvin Grove, Brisbane, Queensland, Australia

Corresponding author:

Judy Munday

Email: [email protected]

Review question/objective

What are the most effective information sharing strategies used to reduce anxiety in families of patients

undergoing elective surgery?

This review seeks to synthesize the best available evidence in relation to the most effective

information-sharing intervention to reduce anxiety for families waiting for patients undergoing an

elective surgical procedure.

The specific objectives are to review the effectiveness of evidence of interventions designed to reduce

the anxiety of families waiting whilst their loved one undergoes a surgical intervention. A variety of

interventions exist and include surgical nurse liaison services, intraoperative reporting either by

face-to-face or telephone delivery, informational cards, visual information screens, and intraoperative

paging devices for families.

Background

The provision of information, preoperative preparation and anxiety reduction for surgical patients has

been the dominant focus in surgical care literature; however the care of the families of surgical patients

also deserves attention. For the purpose of this systematic review, the term ‘family’ is defined as a

self-defined group of individuals who derive support from each other.1 Families most often provide the

backbone of physical and emotional support for patients in the postoperative phase. This is increasingly

the case as patients are now being discharged from hospital postoperatively ‘sooner and sicker.’2,p424

In addition, as surgical episodes increase across the world, more family members are experiencing

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periods of waiting for their loved ones during surgery.3 Anxiety, that is, cognitive, affective and

behavioural disturbances provoked by stress and situations perceived as threatening,4 is common

amongst family members waiting for patients undergoing surgical procedures.5

Family involvement in care has been well researched and explored in a number of specialty areas

including intensive and critical care,6,7

oncology8 and cardiothoracic

9 environments. This aspect of care

is also of importance to perioperative services. Whilst, waiting in all healthcare environments is stressful

regardless of the type of procedure or event that is being waited for,3 in the perioperative areas it has

been suggested that there may also be a conflict between the intrinsically technology-driven

environment and holistic care10

that is understood to benefit patients and relatives alike. During busy

surgical lists it is common for the waiting family to be overlooked while care is provided to patients,11,12

but, as health care providers, we should strive to ensure that the human side of patient care does not

get lost amongst routine and technology.13

Families are increasingly expected to take an active part in care provision,14

but in the same way that

patient anxiety can affect surgical outcome and recovery,15

family anxiety and being under-informed

may impair the family’s ability to effectively carry out these activities. In some areas of the world, family

involvement in hospital care is not only desirable but vital due to nursing staff shortages.16

The

importance of family involvement has been established17

as a key theme in the preoperative

preparation for surgical patients but it also has a critical role in the extended postoperative recovery

phase, both in hospital and upon discharge. Thereby, it is necessary to recognise the barriers to patient

support arising from family anxiety states and to take steps to increase the family’s capacity for

involvement with care.

It has been asserted that by addressing family members’ anxiety, surgical patients will benefit from

greater involvement of and support from the family.9 Involvement in preoperative preparation can aid

family members to feel in control and positive about the impending surgery. However, the time when

anxiety is most heightened is when family members are waiting, most often in holding areas or waiting

rooms during procedures. The environment of the waiting area available for family members can either

present as an aggravating or helping factor18

during this time. Appropriately designed facilities can ease

the waiting period, as opposed to areas that are noisy, cluttered and lack privacy.19

The provision of a

private space in which to converse with healthcare staff has been shown to be considered important by

patients and families18

and also aids the preservation of confidentiality. The presence or absence of a

private space within waiting facilities can therefore be a facilitating or inhibiting factor in the

communication of information from healthcare providers to patients and families during the

perioperative process.

The period of time that families spend waiting for patients during or ‘the wait’ as it has been called,20

is

often characterised by anxiety and uncertainty: these feelings are common regardless of the duration or

type of surgery.3 Much may be at stake for both patient and family alike, especially if the surgery is

particularly extensive or malignancy-related. This period is also influenced by what has been called

‘unknowns:’20

factors that are beyond our control but have a bearing on the outcome of surgery.

These ‘unknowns’ may include surgical risks associated with the procedure, how long the surgery will

take to perform and the outcome of surgery, which may be diagnostic.20

For many it will appear that

time is moving more slowly than normal.12

Family members experience disruption to their normal daily

lives12

whilst spending time in hospital. This can also promote negative emotions and anxiety on the day

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of surgery. Recognition of the multiple stressors that can impact on family members at this time is

crucial to the provision of holistic care. Acknowledgement of this difficult time for family members can

decrease their sense of vulnerability13

and anxiety, and may increase their ability to retain information

and actively care for their relative. Prior experiences of waiting for family members during surgery, or

even prior surgical experiences of the ‘waiters’ themselves can be a contributing factor to anxiety levels.

Or conversely, such memories may also be a comforting factor, depending on the nature of the prior

experience(s), although as one patient in Trimm’s study of spousal coping during surgical waiting noted,

the wait is ‘always like a first time’.20

Fears and anxiety can be increased by a lack of communication between healthcare staff and family

during the waiting period, particularly when families are not informed of the progress of surgery, and of

any delays to expected timeframes12

– a common occurrence in operating theatre schedules. During

the preoperative phase, both patients and family members are commonly approached by many different

multidisciplinary healthcare workers. Inconsistencies in information and fragmentation of

communication10

will add to both patient and family distress. Dissatisfaction with care and associated

anxiety may also grow when family members become frustrated with gaps in information: more

information may be expected during surgical waiting than is, or can be, provided.16,5

Indeed, improved

communication between healthcare professionals and family members is thought to increase

satisfaction levels at the same time as decreasing anxiety during the surgical waiting period.10

The provision of information to reduce family anxiety is a well-established concept in nursing literature.

It is clear that access to information appears to be a high priority for both patients and family members:

patients themselves find comfort in the reassurance that their relatives will be kept well informed during

their surgical procedure.19

Information provision can satisfy both practical and emotional needs. The

type of information provided to family members often involves discussion of timeframes, progress of

surgery and recovery stays. This type of information serves a practical need for families in terms of

visiting the patient and organizing the day’s activities, and perhaps the routines of the extended family.

Emotional needs are also served by this type of information: families experience reassurance when

informed that the surgery is complete and the patient is entering the Recovery room.

Numerous studies have sought to test interventions that provide information to patients and their ability

to alleviate anxiety for waiting families during surgery.2,5,9,21-23

Personal and individualised interventions,

as provided by face-to-face information reports during surgery, have been widely used. Alternatively,

interventions that are less individualised (such as informational cards) and more remote (such as

information reporting via telephone call) have also been tested. Some methods of information reporting

allow for greater freedom of movement of relatives away from the surgical waiting area, such as paging

devices. Indeed, as technology advances, the particular interventions available reflect this, eg surgical

‘tweeting’ was publicised as a relatively recent development.24

The merits, including the

appropriateness and effectiveness of all types of interventions, need to be evaluated.

In-person information focuses on the more traditional methods of a healthcare professional

approaching the family member to provide an update about their loved one’s progress through the

surgical procedure. Face-to-face information is typically delivered at various time intervals: from halfway

through the procedure,2 to every half

5 to two hours.

25 This type of information provision typically involves

a report relating to the progress of and any unexpected delays in the surgery, and appears to be usually

performed by nursing personnel, often referred to as Surgical Liaison Nurse (SLN). The background of

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SLNs performing this role has been open to discussion. Post-anaesthetic care nurses as well as

scrub-scout/theatre nurses have been identified as suitable candidates for the role.10,26

,27

Regardless of

the background of the information provider, sound communication skills and knowledge about the

surgical care process is required.10

The benefits of an SLN’s presence may encompass answering

questions from concerned relatives, as well as providing a soothing presence during the period of

anxiety. It has been suggested that it is perhaps the presence of a supportive person rather than the

actual information relayed that relieves anxiety the most during this time.2 Simply receiving attention

can bring about a change in mood or thought, as demonstrated by findings from Silva’s study of

orientation information on spousal anxiety during surgery28

which suggested that receiving attention

from the investigator resulted in less anxiety amongst some participants.

Information relay between healthcare staff and waiting families can also occur without the physical

presence of a healthcare staff member. Basic interventions, such as simple informational cards22

and

information visual display screens5 have been described: these provide less interpersonal support but

may still have value in providing basic information to patients, in turn relieving anxiety. Interventions

have been organised to allow freedom of movement away from perioperative waiting areas, such as the

use of paging devices23

described above. Again, with these interventions the question remains as to the

most effective timing for these interventions and what information to present in this manner. These

methods of information provision lack the physical dimension of face-to-face information provision, as

well as the ability for communication to be two-way and the opportunity for either party to ask questions.

In fact, it may be that efforts to personalise nursing care have come full circle with the employment of

some technology-driven and remote methods actually de-personalising communication between

healthcare providers, patients and families. In contrast, traditional face-to-face interventions to alleviate

anxiety for families during surgical waiting may promote personalisation of care in the perioperative

environment.

Although various ways of delivering information to waiting family members have been investigated, the

effectiveness of one intervention over another has not been established, nor timings for these

interventions. A systematic review29

evaluating how the provision of information to family affects their

anxiety was published in 2001: the objective of this 2001 review focused on investigating changes that

surgery providers needed to make when providing information in the USA due to impending privacy

regulations. A new systematic review on this topic will enable more recent studies to be evaluated and

will not restrict or focus findings to one healthcare system alone. In addition, this review will aim to bring

clarity to the characteristics of effective information-giving interventions to families, eliminating any

confusion caused from the conflicting results between existing single studies.9,28

Preliminary searching reveals a significant number of studies of interventions utilizing information-

giving to reduce anxiety amongst families during surgical waiting that can be evaluated in order to

provide recommendations of effectiveness. This would be valuable in the context of current healthcare

trends, where patients are often discharged sooner and often rely upon family members to provide

support in the initial post discharge phase; hence the emotional and coping status of family members

needs to be optimized. This is particularly relevant in the context of providing holistic care to patients,

encompassing and including those closest to them throughout their experience of surgery. In addition,

these recommendations will also enable healthcare providers to focus resources and time on effective

strategies. This is a subject not yet addressed by a systematic review.

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Keywords: anxiety; information needs; family; surgery; perioperative; intraoperative reporting; surgical

liaison nurse

Inclusion criteria

Types of participants

All studies of family members over 18 years of age waiting for patients undergoing an elective surgical

procedure will be included, including those waiting for both adult and paediatric patients. Studies of

families waiting for other patient populations, eg emergency surgery, chemotherapy or intensive care

patients will be excluded.

Types of intervention(s)/phenomena of interest

All information-sharing Interventions for families of patients undergoing an elective surgical procedure

will be included, including but not limited to: surgical nurse liaison services, in-person intraoperative

reporting, visual information screens, paging devices, informational cards and telephone delivery of

intraoperative progress reports. Interventions that take place during the intraoperative phase of care

only will be included in the review. Preadmission information sharing interventions will be excluded.

Types of outcomes

The outcomes of interest include:

Primary outcome: the level of anxiety amongst family members or close relatives whilst waiting for

patients undergoing surgery, as measured by a validated instrument (such as the S-Anxiety portion of

the State-Trait Anxiety Inventory).4

Secondary outcomes: family satisfaction and other measurements that may be considered indicators of

stress and anxiety, such as mean arterial pressure (MAP) and heart rate.

Types of studies

This review will include all randomized controlled trial (RCTs) quasi-experimental studies,

case-controlled and descriptive studies, comparing one information-sharing intervention to another or to

usual care.

Search strategy

The search strategy will aim to find both published and unpublished literature, including grey literature,

in English language only. A three-step search strategy will be utilized. An initial limited search of

Medline, CINAHL and EMBASE will be conducted, followed by an analysis of the text words contained

in the title and abstract, and the index terms used to describe the article. A second search will include all

identified keywords and index terms across all databases listed. Thirdly, the reference lists of all

identified studies and articles will be hand searched. The date range for searches will be from 1990 until

April 2013, as it is known that a number of studies were conducted during the 1990s that could

potentially be included in the review.

Databases to be searched will include Medline, CINAHL, EMBASE, ProQuest, Web of Science,

PsycINFO, Scopus, Dissertation and Theses PQDT (via ProQuest), Current Contents, CENTRAL,

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Google Scholar, OpenGrey, Clinical Trials, Science.gov, Current Controlled Trials and National Institute

for Clinical Studies (NHMRC).

All studies identified during the database search will be assessed for relevance to the review based on

information via the title, abstract and description by two independent reviewers. A third reviewer will be

consulted if consensus cannot be reached. The full article will be retrieved for all those that appear to

meet the inclusion criteria. Any articles that appear unclear in this respect will also be retrieved for

clarification. Initial keywords : perioperative or peri-operative or intra-operative, surgical, anxiety, information needs

Method of the review

Verification of relevance

All studies will be assessed for relevance to the inclusion criteria using a form developed by the

reviewers and based on the recommendations of the Cochrane Collaboration (Appendix I).30

Assessment of methodological quality

Papers selected for retrieval will be assessed for methodological quality by two independent reviewers

prior for inclusion in the review using the standardized critical appraisal instruments for randomised

controlled trials (Appendix II), descriptive studies (Appendix III) and cohort/case controlled studies

(Appendix IV) from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review

Instruments (JBI-MAStARI). Disagreements will be resolved via discussion or by consultation with the

third reviewer.

Data collection

Quantitative data will be extracted independently by two reviewers from the included papers using a

customised data extraction tool developed and piloted by the authors (Appendix V). The extracted data

will include details of the intervention, population, study methods and outcomes relevant to the review

question and objectives. Attempts will be made to contact authors of studies if data is missing or if

clarification is required regarding unclear data.

Data synthesis

All results will be subject to double data entry. Where statistical pooling is possible, the results will be

analysed using JBI-MAStARI software. Odds ratio (for categorical data) and weighted mean difference

(for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity

will be calculated using the standard Chi-square test. Where statistical pooling is not possible, the

results will be presented in narrative form.

Conflicts of interest

No potential conflicts of interest are identified.

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References In

1. Majasaari H, Sarajarvi A, Koskinen H, Autere S, Paavilainen E. Patients' Perceptions of Emotional Support and Information Provided to Family Members. Aorn Journal. 2005; 81(5): 1030–9.

2. Leske JS. Intraoperative progress reports decrease family members’ anxiety. AORN Journal. 1996; 64(Sept): 424–35.

3. Trimm DR, Sanford JT. The Process of family waiting during surgery. Journal of Family Nursing. 2010; 16(4): 435–61.

4. Spielberger CD. Anxiety: State-Trait Process. In: Spielberger CD, Sarason IG, editor. Stress and Anxiety. Volume 1. Washington, United States, Washington: Hemisphere Publishing Corporation; 1975; 115–43.

5. Lerman Y, Kara I, Porat N. Nurse Liaison: The Bridge Between the Perioperative Department and Patient. AORN [Internet]. AORN, Inc.; 2011; 94(4): 385–92. Available from: http://dx.doi.org/10.1016/j.aorn.2011.01.019

6. Chien WT, Chiu YL, Lam LW, & Ip WY. Effects of a needs-based education programme family carers with a relative in an intensive care unit: a quasi-experimental study. International Journal of Nursing studies. 2006; 43(1): 39–50.

7. DeJong MJ, Beatty DS. Family perceptions of support interventions in the intensive care unit. Dimensions in critical care nursing. 2000; 19(5): 40–7.

8. Cunningham MF, Hanson-Heath C, Agre P. A Perioperative Nurse Liaison Program. CNS Interventions for Cancer Patients and Their Families. Journal of Nursing Care Quality. 2003; January-Ma: 16–21.

9. Trecartin K, Carroll DL. Nursing interventions for family members waiting during cardiac procecdures. Clinical Nursing Research. 2011; 20(3): 263–75.

10. Stephens-woods K, Joseph S, Nurses TP, Care PH, Standards OR, Statements P, et al. L ’ IMPACT DE L ' E ^ iFIRMIÈRE / INFIRMIER DE LIAISON SUR LA SATISFACTION DU PATIENT THE IMPACT OE THE SURGICAL LIAISON NURSE ON PATIENT SATISFACTION IN THE PERIOPERATIVE. Canadian operating room nursing journal. 2008; 26(4): 6–11.

11. Ivarsson B, Larsson S, Lührs C, Sjöberg T. Serious complications in connection with cardiac surgery--next of kin’s views on information and support. Intensive & critical care nursing : the official journal of the British Association of Critical Care Nurses [Internet]. Elsevier Ltd; 2011 Dec [cited 2013 Mar 11]; 27(6): 331–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22055397

12. Silva MC, Geary ML, Manning B, Zeccolo PG. Caring for those who wait. Today’s OR Nurse. 1984; 6(6): 26–30.

13. Dowey P. Loneliness in the waiting room. Canadian Nurse. 2005; 101(2): 6–7.

14. Weeks TA. Behind the red line : The intraoperative experience of those who wait. Gonzaga University; 2000.

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15. Bellani ML. Psychological aspects in day-case surgery. International Journal of Surgery [Internet]. Elsevier Ltd; 2008; 6: S44–S46. Available from: http://dx.doi.org/10.1016/j.ijsu.2008.12.019

16. Sayin Y, Aksoy G. The nurse’s role in providing information to surgical patients and family members in Turkey: a descriptive study. AORN journal [Internet]. 2012 Jun [cited 2013 Mar 11]; 95(6): 772–87. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22633384

17. Chan Z, Kan C, Lee P, Chan I, Lam J. A systematic review of qualitative studies : patients ’

experiences of preoperative communication. Journal of Clinical Nursing. 2011; 21: 812–24.

18. Carmichael JM, Agre P. Preferences in surgical waiting area amenities. AORN journal [Internet]. 2002 Jun; 75(6): 1077–83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12085400

19. Bailey J, Mcvey L. Surveying Patients as a Start to Quality Improvement in the Surgical Suites Holding Area. Journal of Nursing Care Quality. 2005; 20(4):319–26.

20. Trimm D. Spousal Coping During the Surgical Wait. Journal of PeriAnesthesia Nursing. 1997; 12(3): 141–51.

21. MacDonald K, Latimer M, Drisdelle N. Determining the impact of a surgical liaison nurse role in the paediatric operating room. Canadian operating room nursing journal [Internet]. 2006; 24(1): 7–8, 10–1, 13–4 passim. Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16623314

22. Muldoon M, Cheng D, Vish N. Implementation of an Informational Card to Reduce Family Members’ Anxiety. AORN [Internet]. AORN, Inc.; 2011; 94(3): 246–53. Available from: http://dx.doi.org/10.1016/j.aorn.2011.01.016

23. Topp R, Walsh E, Sanford C. Can providing paging devices relieve waiting room anxiety ? AORN Journal. 1998; 67(4): 852–61.

24. Crumb M. Surgery tweets New way to keep family in loop - Health - Health care NBC News [Internet]. 2009 [cited 2013 Feb 19]. Available from: http://phys.org/news171121774.html

25. Carmody S, Hickey P, Bookbinder M. Perioperative Needs of Families. Aorn Journal. 1991; 54(3): 561–7.

26. O’ Connell M. Special presentation: anxiety reduction in family members of patients in surery and postanesthesia care: a pilot study. Journal of Post Anesthesia Nursing. 1989; 4(1): 7–16.

27. Stefan KANN. The Nurse Liaison in Perioperative Services : A Family-Centered Approach. AORN [Internet]. AORN, Inc.; 2010; 92(2): 150–7. Available from: http://dx.doi.org/10.1016/j.aorn.2009.11.070

28. Silva MC. Effects of Orientation Information on Spouses ’ Anxieties and Attitudes Toward Hospitalization and Surgery. Research in nursing and health. 1979; 2: 127–36.

29. Dexter F, Epstein RH. Reducing Family Members ’ Anxiety While Waiting on the Day of Surgery : Systematic Review of Studies and Implications of HIPAA Health Information Privacy Rules. Journal of clinical anesthesia. 2001;13:478–81.

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30. Higgins JPT, Deeks JJ. Chapter 7: Selecting studies and collecting data. In: Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011. The Cochrane Collaboration.; 2011.

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Appendix I: Verification of study eligibility

Inclusion criteria

AUTHOR AND YEAR

JOURNAL

TITLE

REVIEWER

Population: The study population is family members of patients undergoing elective surgery

Yes

Intervention: The study participants received interventions to provide information and reduce anxiety

whilst awaiting patients undergoing surgical procedures

Yes

Outcome: The primary or secondary outcomes include reduction of anxiety

Yes

Language: The study is in English

Yes

IF YOU HAVE NOT ANSWERED YES TO ALL OF THE ABOVE QUESTIONS, YOU SHOULD

EXCLUDE THE STUDY. IF YOU ANSWERED YES TO ALL, PLEASE CONTINUE.

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Appendix II: Appraisal instruments

MAStARI appraisal instrument test message

Insert

Appendix

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Appendix III: Appraisal instruments

MAStARI appraisal instrument

A

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Appendix IV: Appraisal instruments

MAStARI appraisal instrument

a test message

Insert page break

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Appendix V: Data extraction form

Reduction of anxiety for family members of patients undergoing surgery: data extraction tool

Record number

Author

Journal

Year Reviewer

Study method

Setting

PARTICIPANTS

Control group Intervention group

Number in group

Mean age and range

Female

Male

Relationship

Parent of patient

Child of patient

Spouse

Other relationship

Highest education level

Basic education

Secondary/high school

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Post-secondary/ non-university

University

Type of surgery

Excluded participants

Patients who left the study &

why

INTERVENTION

Control group Intervention group

Types of interventions

Timings of interventions

Content of information provided

OUTCOME

Control group Intervention group

State anxiety scores*(STAI S-Anxiety)

Other anxiety score

Mean arterial pressure

Heart rate

Satisfaction score

Other outcomes

*S-Anxiety portion of the State-Trait Anxiety Inventory (STAI) Form Y4

RESULTS

Dichotomous data

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Outcome Control group number/total

number

Intervention group number/total

number

Continuous data

Outcome Control Group Mean and

Standard Deviation SD

(number)

Intervention Group Mean and

Standard Deviation SD (number)