Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2013, Issue 10 http://www.thecochranelibrary.com Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 4 METHODS ...................................... 4 RESULTS....................................... 10 Figure1. ..................................... 13 Figure2. ..................................... 14 DISCUSSION ..................................... 17 AUTHORS’CONCLUSIONS . 20 ACKNOWLEDGEMENTS . 21 REFERENCES ..................................... 22 CHARACTERISTICSOFSTUDIES . 33 DATAANDANALYSES. 103 Analysis 1.1. Comparison 1 Distraction, Outcome 1 Self-reportedpain.. 105 Analysis 1.2. Comparison 1 Distraction, Outcome 2 Observer-reported pain. 106 Analysis 1.3. Comparison 1 Distraction, Outcome 3 Self-reported distress. 107 Analysis 1.4. Comparison 1 Distraction, Outcome 4 Observer-reported distress. 107 Analysis 1.5. Comparison 1 Distraction, Outcome 5 Behavioral measures- Pain. 108 Analysis 1.6. Comparison 1 Distraction, Outcome 6 Behavioral measures- Distress. 109 Analysis 1.7. Comparison 1 Distraction, Outcome 7 Physiological measure - Heart Rate. 110 Analysis 1.8. Comparison 1 Distraction, Outcome 8 Physiological measure - Oxygen Saturation. 110 Analysis 2.1. Comparison 2 Hypnosis, Outcome 1 Self-reported pain. ................ 111 Analysis 2.2. Comparison 2 Hypnosis, Outcome 2 Self-reported distress. 112 Analysis 2.3. Comparison 2 Hypnosis, Outcome 3 Behavioral measures- Distress. 113 Analysis 3.1. Comparison 3 Preparation and information, Outcome 1 Self-reported pain. 114 Analysis 4.1. Comparison 4 Virtual reality, Outcome 1 Self-reported pain. 114 Analysis 5.1. Comparison 5 CBT-combined, Outcome 1 Self-reportedpain. 115 Analysis 5.2. Comparison 5 CBT-combined, Outcome 2 Self-reported distress. 116 Analysis 5.3. Comparison 5 CBT-combined, Outcome 3 Observer-reported distress. 116 Analysis 5.4. Comparison 5 CBT-combined, Outcome 4 Behavioral measures- Distress. 117 Analysis 6.1. Comparison 6 Parent coaching + child distraction, Outcome 1 Self-reported pain. 118 Analysis 6.2. Comparison 6 Parent coaching + child distraction, Outcome 2 Observer-reported distress. 118 Analysis 6.3. Comparison 6 Parent coaching + child distraction, Outcome 3 Behavioral measures- Distress. 119 Analysis 7.1. Comparison 7 Suggestion, Outcome 1 Self-reportedpain. ... ... ... ... ... 120 ADDITIONALTABLES. 120 APPENDICES ..................................... 124 WHAT’SNEW..................................... 133 HISTORY....................................... 133 CONTRIBUTIONSOFAUTHORS . 134 DECLARATIONSOFINTEREST . 134 SOURCESOFSUPPORT . 134 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 135 NOTES........................................ 135 INDEXTERMS .................................... 135 Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) i Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Psychological interventions for needle-related procedural pain and distress in children and adolescents Lindsay S Uman1, Kathryn A Birnie2, Melanie Noel2, Jennifer A Parker2, Christine T Chambers3, Patrick J McGrath3, Steve R Kisely 4 1IWK Health Centre & Dalhousie University, Halifax, Canada. 2Centre for Pediatric Pain Research, IWK Health Centre, Halifax, Canada. 3Department of Psychology, Dalhousie University, Department of Pediatrics (GI Division), IWK Health Centre, Halifax, Canada. 4School of Population Health, The University of Queensland, Brisbane, Australia Contact address: Christine T Chambers, Department of Psychology, Dalhousie University, Department of Pediatrics (GI Division), IWK Health Centre, 5850/5980 University Avenue, P.O. Box 9700, Halifax, Noval Scotia, B3K 6R8, Canada. [email protected]. Editorial group: Cochrane Pain, Palliative and Supportive Care Group. Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 10, 2013. Review content assessed as up-to-date: 2 September 2013. Citation: Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle- related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD005179. DOI: 10.1002/14651858.CD005179.pub3. Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background This review is an updated version of the original Cochrane review published in Issue 4, 2006. Needle-related procedures are a common source of pain and distress for children. Our previous review on this topic indicated that a number of psychological interventions were efficacious in managing pediatric needle pain, including distraction, hypnosis, and combined cognitive behavioural interventions. Considerable additional research in the area has been published since that time. Objectives To provide an update to our 2006 review assessing the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents. Search methods Searches of the following databases were conducted for relevant randomized controlled trials (RCTs): Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; PsycINFO; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and Web of Science. Requests for relevant studies were also posted on various electronic list servers. We ran an updated search in March 2012, and again in March 2013. Selection criteria Participants included children and adolescents aged two to 19 years undergoing needle-related procedures. Only RCTs with at least five participants in each study arm comparing a psychological intervention group with a control or comparison group were eligible for inclusion. Data collection and analysis Two review authors extracted data and assessed trial quality and a third author helped with data extraction and coding for one non- English study. Included studies were coded for quality using the Cochrane Risk of bias tool. Standardized mean differences with 95% confidence intervals were computed for all analyses using Review Manager 5.2 software. Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 1 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results Thirty-nine trials with 3394 participants were included. The most commonly studied needle procedures were venipuncture, intravenous (IV) line insertion, and immunization. Studies included children aged two to 19 years, with the most evidence available for children under 12 years of age. Consistent with the original review, the most commonly studied psychological interventions for needle procedures were distraction, hypnosis, and cognitive behavioural therapy (CBT). The majority of included studies (19 of 39) examined distraction only. The additional studies from this review update continued to provide strong evidence for the efficacy of distraction and hypnosis. No evidence was available to support the efficacy of preparation and information, combined CBT (at least two or more cognitive or behavioural strategies combined), parent coaching plus distraction, suggestion, or virtual reality for reducing children’s pain and distress. No conclusions could be drawn about interventions of memory alteration, parent positioning plus distraction, blowing out air, or distraction plus suggestion, as evidence was available from single studies only. In addition, the Risk of bias scores indicated several domains with high or unclear bias scores (for example, selection, detection, and performance bias) suggesting that the methodological rigour and reporting of RCTs of psychological interventions continue to have considerable room for improvement. Authors’ conclusions Overall, there is strong evidence supporting the efficacy of distraction and hypnosis for needle-related pain and distress in children and adolescents, with no evidence currently available for preparation and information or both, combined CBT, parent coaching plus distraction, suggestion, or virtual reality. Additional research is needed to further assess interventions that have only been investigated in one RCT to date (that is, memory alteration, parent positioning plus distraction, blowing out air, and distraction plus suggestion). There are continuing issues with the quality of trials examining psychological interventions for needle-related pain and distress. PLAIN LANGUAGE SUMMARY Psychological interventions for needle-related procedural pain and distress in children and adolescents Psychological interventions (for example, distraction, hypnosis, coping skills training) are treatments used to reduce pain and distress (anxiety and fear, or both) that children and adolescents experience while undergoing