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Meta-Analysis
. 2018 Oct 4;10(10):CD005179.
doi: 10.1002/14651858.CD005179.pub4.

Psychological interventions for needle-related procedural pain and distress in children and adolescents

Kathryn A Birnie  1 , Melanie Noel, Christine T Chambers, Lindsay S Uman, Jennifer A Parker
Affiliations
Meta-Analysis

Psychological interventions for needle-related procedural pain and distress in children and adolescents

Kathryn A Birnie et al. Cochrane Database Syst Rev. .

Abstract

Background: This is the second update of a Cochrane Review (Issue 4, 2006). Pain and distress from needle-related procedures are common during childhood and can be reduced through use of psychological interventions (cognitive or behavioral strategies, or both). Our first review update (Issue 10, 2013) showed efficacy of distraction and hypnosis for needle-related pain and distress in children and adolescents.

Objectives: To assess the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents.

Search methods: We searched six electronic databases for relevant trials: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; PsycINFO; Embase; Web of Science (ISI Web of Knowledge); and Cumulative Index to Nursing and Allied Health Literature (CINAHL). We sent requests for additional studies to pediatric pain and child health electronic listservs. We also searched registries for relevant completed trials: clinicaltrials.gov; and World Health Organization International Clinical Trials Registry Platform (www.who.int.trialsearch). We conducted searches up to September 2017 to identify records published since the last review update in 2013.

Selection criteria: We included peer-reviewed published randomized controlled trials (RCTs) with at least five participants per study arm, comparing a psychological intervention with a control or comparison group. Trials involved children aged two to 19 years undergoing any needle-related medical procedure.

Data collection and analysis: Two review authors extracted data and assessed risks of bias using the Cochrane 'Risk of bias' tool. We examined pain and distress assessed by child self-report, observer global report, and behavioral measurement (primary outcomes). We also examined any reported physiological outcomes and adverse events (secondary outcomes). We used meta-analysis to assess the efficacy of identified psychological interventions relative to a comparator (i.e. no treatment, other active treatment, treatment as usual, or waitlist) for each outcome separately. We used Review Manager 5 software to compute standardized mean differences (SMDs) with 95% confidence intervals (CIs), and GRADE to assess the quality of the evidence.

Main results: We included 59 trials (20 new for this update) with 5550 participants. Needle procedures primarily included venipuncture, intravenous insertion, and vaccine injections. Studies included children aged two to 19 years, with few trials focused on adolescents. The most common psychological interventions were distraction (n = 32), combined cognitive behavioral therapy (CBT; n = 18), and hypnosis (n = 8). Preparation/information (n = 4), breathing (n = 4), suggestion (n = 3), and memory alteration (n = 1) were also included. Control groups were often 'standard care', which varied across studies. Across all studies, 'Risk of bias' scores indicated several domains at high or unclear risk, most notably allocation concealment, blinding of participants and outcome assessment, and selective reporting. We downgraded the quality of evidence largely due to serious study limitations, inconsistency, and imprecision.Very low- to low-quality evidence supported the efficacy of distraction for self-reported pain (n = 30, 2802 participants; SMD -0.56, 95% CI -0.78 to -0.33) and distress (n = 4, 426 participants; SMD -0.82, 95% CI -1.45 to -0.18), observer-reported pain (n = 11, 1512 participants; SMD -0.62, 95% CI -1.00 to -0.23) and distress (n = 5, 1067 participants; SMD -0.72, 95% CI -1.41 to -0.03), and behavioral distress (n = 7, 500 participants; SMD -0.44, 95% CI -0.84 to -0.04). Distraction was not efficacious for behavioral pain (n = 4, 309 participants; SMD -0.33, 95% CI -0.69 to 0.03). Very low-quality evidence indicated hypnosis was efficacious for reducing self-reported pain (n = 5, 176 participants; SMD -1.40, 95% CI -2.32 to -0.48) and distress (n = 5, 176 participants; SMD -2.53, 95% CI -3.93 to -1.12), and behavioral distress (n = 6, 193 participants; SMD -1.15, 95% CI -1.76 to -0.53), but not behavioral pain (n = 2, 69 participants; SMD -0.38, 95% CI -1.57 to 0.81). No studies assessed hypnosis for observer-reported pain and only one study assessed observer-reported distress. Very low- to low-quality evidence supported the efficacy of combined CBT for observer-reported pain (n = 4, 385 participants; SMD -0.52, 95% CI -0.73 to -0.30) and behavioral distress (n = 11, 1105 participants; SMD -0.40, 95% CI -0.67 to -0.14), but not self-reported pain (n = 14, 1359 participants; SMD -0.27, 95% CI -0.58 to 0.03), self-reported distress (n = 6, 234 participants; SMD -0.26, 95% CI -0.56 to 0.04), observer-reported distress (n = 6, 765 participants; SMD 0.08, 95% CI -0.34 to 0.50), or behavioral pain (n = 2, 95 participants; SMD -0.65, 95% CI -2.36 to 1.06). Very low-quality evidence showed efficacy of breathing interventions for self-reported pain (n = 4, 298 participants; SMD -1.04, 95% CI -1.86 to -0.22), but there were too few studies for meta-analysis of other outcomes. Very low-quality evidence revealed no effect for preparation/information (n = 4, 313 participants) or suggestion (n = 3, 218 participants) for any pain or distress outcome. Given only a single trial, we could draw no conclusions about memory alteration. Adverse events of respiratory difficulties were only reported in one breathing intervention.

Authors' conclusions: We identified evidence supporting the efficacy of distraction, hypnosis, combined CBT, and breathing interventions for reducing children's needle-related pain or distress, or both. Support for the efficacy of combined CBT and breathing interventions is new from our last review update due to the availability of new evidence. The quality of trials and overall evidence remains low to very low, underscoring the need for improved methodological rigor and trial reporting. Despite low-quality evidence, the potential benefits of reduced pain or distress or both support the evidence in favor of using these interventions in clinical practice.

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Conflict of interest statement

  1. KA Birnie: none known. Dr. Birnie is a registered psychologist and works with children, adolescents, adults, and their families with pain and other acute and chronic illness.

  2. M Noel: none known. Dr. Noel is a registered psychologist and works with children and adolescents with acute and chronic illness, and their families.

  3. CT Chambers: none known. Dr. Chambers is a registered psychologist and works with children and their families with pain and other acute and chronic illness.

  4. LS Uman: none known. Dr. Uman is a registered psychologist who works with youth and their families to address complex pain, other health‐related issues, and a variety of mental health concerns.

  5. JA Parker: none known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 Distraction, outcome: 1.1 Self‐reported pain.
5
5
Forest plot of comparison: 2 CBT‐combined, outcome: 2.1 Self‐reported pain.
6
6
Forest plot of comparison: 3 Hypnosis, outcome: 3.1 Self‐reported pain.
7
7
Forest plot of comparison: 4 Preparation/Information, outcome: 4.1 Self‐reported pain.
8
8
Forest plot of comparison: 5 Breathing, outcome: 5.1 Self‐reported pain.
9
9
Forest plot of comparison: 6 Suggestion, outcome: 6.1 Self‐reported pain.
1.1
1.1. Analysis
Comparison 1: Distraction, Outcome 1: Self‐reported pain
1.2
1.2. Analysis
Comparison 1: Distraction, Outcome 2: Self‐reported distress
1.3
1.3. Analysis
Comparison 1: Distraction, Outcome 3: Observer‐reported pain
1.4
1.4. Analysis
Comparison 1: Distraction, Outcome 4: Observer‐reported distress
1.5
1.5. Analysis
Comparison 1: Distraction, Outcome 5: Behavioral measures‐ Pain
1.6
1.6. Analysis
Comparison 1: Distraction, Outcome 6: Behavioral measures‐ Distress
1.7
1.7. Analysis
Comparison 1: Distraction, Outcome 7: Physiological measure ‐ heart rate
1.8
1.8. Analysis
Comparison 1: Distraction, Outcome 8: Physiological measure ‐ oxygen saturation
2.1
2.1. Analysis
Comparison 2: CBT‐combined, Outcome 1: Self‐reported pain
2.2
2.2. Analysis
Comparison 2: CBT‐combined, Outcome 2: Self‐reported distress
2.3
2.3. Analysis
Comparison 2: CBT‐combined, Outcome 3: Observer‐reported pain
2.4
2.4. Analysis
Comparison 2: CBT‐combined, Outcome 4: Observer‐reported distress
2.5
2.5. Analysis
Comparison 2: CBT‐combined, Outcome 5: Behavioral measures‐ Pain
2.6
2.6. Analysis
Comparison 2: CBT‐combined, Outcome 6: Behavioral measures‐ Distress
2.7
2.7. Analysis
Comparison 2: CBT‐combined, Outcome 7: Physiological measure ‐ Cortisol
3.1
3.1. Analysis
Comparison 3: Hypnosis, Outcome 1: Self‐reported pain
3.2
3.2. Analysis
Comparison 3: Hypnosis, Outcome 2: Self‐reported distress
3.3
3.3. Analysis
Comparison 3: Hypnosis, Outcome 3: Behavioral measures‐ Pain
3.4
3.4. Analysis
Comparison 3: Hypnosis, Outcome 4: Behavioral measures‐ Distress
4.1
4.1. Analysis
Comparison 4: Preparation/Information, Outcome 1: Self‐reported pain
4.2
4.2. Analysis
Comparison 4: Preparation/Information, Outcome 2: Observer‐reported pain
5.1
5.1. Analysis
Comparison 5: Breathing, Outcome 1: Self‐reported pain
6.1
6.1. Analysis
Comparison 6: Suggestion, Outcome 1: Self‐reported pain
See this image and copyright information in PMC

Update of

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    1. Berberich FR, Landman Z. Reducing immunization discomfort in 4- to 6-year-old children: A randomized clinical trial. Pediatrics 2009;124(2):e203-9. - PubMed
Berge 2017 {published data only}
    1. Berge KG, Agdal ML, Vika M, Skeie MS. Treatment of intra-oral injection phobia: a randomized delayed intervention controlled trial among Norwegian 10- to 16-year-olds. Acta Odontologica Scandinavica 2017;75(4):294–301. - PubMed
Boivin 2008 {published data only}
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Bowen 1999 {published data only}
    1. Bowen AM, Dammeyer MM. Reducing children's immunization distress in a primary care setting. Journal of Pediatric Nursing 1999;14(5):296-303. - PubMed
Broome 1998 {published data only}
    1. Broome ME, Rehwaldt M, Fogg L. Relationships between cognitive behavioral techniques, temperament, observed distress, and pain reports in children and adolescents during lumbar puncture. Journal of Pediatric Nursing 1998;13(1):48-54. - PubMed
Bruck 1995 {published data only}
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Bufalini 2009 {published data only}
    1. Bufalini A. Role of interactive music in oncological pediatric patients undergoing painful procedures [Ruolo della musica interattiva nel paziente pediatrico oncologico sottoposto a procedure dolorose]. Minerva Pediatrica 2009;61(4):379-90. - PubMed
Bufalini 2012 {unpublished data only}
    1. Bufalini A. The effect of live music on oncological paediatric patients during painful procedures. European Journal of Integrative Medicine 2012.
Carlson 2000 {published data only}
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Chan 2013 {published data only}
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Chen 2000b {published data only}
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Chow 2017 {published data only}
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Christiano 1996 {unpublished data only}
    1. Christiano BA. Children's coping and distress during invasive dental procedures: The effects of matching coping interventions to coping styles [Doctoral dissertation]. Case Western Reserve University, 1996.
Cline 2006 {published data only}
    1. Cline RJ, Harper FW, Penner LA, Peterson AM, Taub JW, Albrecht TL. Parent communication and child pain and distress during painful pediatric cancer treatments. Social Science & Medicine 2006;63(4):883-98. - PubMed
Cohen 1997 {published data only}
    1. Cohen LL, Blount RL, Panopoulos G. Nurse coaching and cartoon distraction: An effective and practical intervention to reduce child, parent, and nurse distress during immunizations. Journal of Pediatric Psychology 1997;22(3):355-70. - PubMed
Cohen 1999 {published data only}
    1. Cohen LL, Blount RL, Jansevics Cohen R, Ball CM, McClellan CB, Bernard RS. Children's expectations and memories of acute distress: Short- and long-term efficacy of pain management interventions. Journal of Pediatric Psychology 2001;26(6):367-74. - PubMed
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Cohen 2002 {published data only}
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Cohen 2010 {published data only}
    1. Cohen L. A multifaceted distraction intervention may reduce pain and discomfort in children 4–6 years of age receiving immunisation. Evidence Based Nursing 2010;13(1):15-6. - PubMed
Cramer‐Berness 2005 {published data only}
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Crowley 2011 {published data only}
    1. Crowley MA, Storer A, Heaton K, Naccarato MK, Proehl JA, Moretz JD, et al. Emergency nursing resource: needle-related procedural pain in pediatric patients in the emergency department. Journal of Emergency Nursing 2011;37(3):246-51. - PubMed
Cumino 2017 {published data only}
    1. Cumino DO, Vieira JE, Lima LC, Stievano LP, Silva RA, Mathias LA. Smartphone-based behavioural intervention alleviates children’s anxiety during anaesthesia induction. European Journal of Anaesthesiology 2017;34(3):169–75. - PubMed
Dahlquist 2002 {published data only}
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Dahlquist 2005 {published data only}
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Davit 2011 {published data only}
    1. Davit CJ, Hundley RJ, Bacic JD, Hanson EM. A pilot study to improve venipuncture compliance in children and adolescents with autism spectrum disorders. Journal of Developmental and Behavioral Pediatrics 2011;32(7):521-5. - PMC - PubMed
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Drahota 2008 {published data only}
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Dufresne 2010 {published data only}
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El‐Sharkawi 2012 {published data only}
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Fancourt 2016 {published data only}
    1. Fancourt D, Lee C, Baltzer Nielsen S, Capps S, Brooks P. Relax anaesthetics: The effect of a bespoke distraction app on anxiety levels in children undergoing induction of anaesthesia. Anesthesia and Analgesia 2016;123(3S):292-3.
Fassler 1985 {published data only}
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Felluga 2016 {published data only (unpublished sought but not used)}
    1. Felluga M, Rabach I, Minute M, Montico M, Giorgi R, Lonciari I, et al. A quasi randomized-controlled trial to evaluate the effectiveness of clowntherapy on children’s anxiety and pain levels in emergency department. European Journal of Pediatrics 2016;175(5):645–50. - PubMed
Firoozi 2014 {published data only}
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Forsner 2014 {published data only}
    1. Forsner M, Norstrom F, Nordyke K, Ivarsson A, Lindh V. Relaxation and guided imagery used with 12-year-olds during venipuncture in a school-based screening study. Journal of Child Health Care 2014;18(3):241-52. - PubMed
Franck 2014 {published data only}
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Franzoi 2016 {published data only}
    1. Franzoi MAH, Goulart CB, Lara EO, Martins G. Music listening for anxiety relief in children in the preoperative period: A randomized clinical trial. Revista Latino-Americana de Enfermagem 2016;24:e2841. - PMC - PubMed
French 1994 {published data only}
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Garret‐Bernardin 2017 {published data only}
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Gilbert 1982 {published data only}
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Goymour 2000 {published data only}
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Hartling 2013 {published data only (unpublished sought but not used)}
    1. Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, et al. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatrics 2013;167(9):826-35. - PubMed
Hatava 2000 {published data only}
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Hawkins 1998 {published data only}
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Heckler‐Medina 2006 {published data only}
    1. Heckler-Medina GA. The importance of child life and pain management during vascular access procedures in pediatrics. Journal of the Association for Vascular Access 2006;11(3):144-51.
Hedén 2009 {published data only}
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Hillgrove‐Stuart 2013 {published data only}
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Hoffman 2011 {published data only}
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Howe 2011 {published data only}
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Inal 2010 {published data only}
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Isong 2014 {published data only}
    1. Isong IA, Rao SR, Holifield C, Iannuzzi D, Hanson E, Ware J, et al. Addressing dental fear in children with Autism Spectrum Disorders: A randomized controlled pilot study using electronic screen media. Clinical Pediatrics 2014;53(3):230–7. - PubMed
Jacobson 2006 {published data only}
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Jay 1987 {published data only}
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Jay 1990 {published data only}
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Jay 1991 {published data only}
    1. Jay SM, Elliott CH, Woody PD. An investigation of cognitive-behavior therapy combined with oral Valium for children undergoing painful medical procedures. Health Psychology 1991;10(5):317-22. - PubMed
Jay 1995 {published data only}
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Jibb 2017 {published data only}
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Jimeno 2014 {published data only}
    1. Jimeno FG, Mercade Bellido M, Cuadros Fernandez C, Lorente Rodriguez AI, Llopis Perez J, Boj Quesada JR. Effect of audiovisual distraction on children’s behaviour, anxiety and pain in the dental setting. European Journal of Paediatric Dentistry 2014;15(3):297-302. - PubMed
Kain 2006 {published data only}
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Kammerbauer 2011 {published data only}
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Kazak 1996 {published data only}
    1. Kazak AE, Penati B, Boyer BA, Himelstein B, Brophy P, Waibel MK, et al. A randomized controlled perspective outcome study of a psychological and pharmacological intervention protocol for procedural distress in pediatric leukemia. Journal of Pediatric Psychology 1996;21(5):615-31. - PubMed
Kazak 1998 {published data only}
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Kearl 2015 {published data only}
    1. Kearl YL, Yanger S, Montero S, Morelos-Howard E, Claudius I. Does combined use of the J-tip and Buzzy device decrease the pain of venipuncture in a pediatric population? Journal of Pediatric Nursing 2015;30(6):829–33. - PubMed
Kettwich 2007 {published data only}
    1. Kettwich SC, Sibbitt WL Jr, Brandt JR, Johnson CR, Wong CS, Bankhurst AD. Needle phobia and stress-reducing medical devices in pediatric and adult chemotherapy patients. Journal of Pediatric Oncology Nursing 2007;24(1):20-8. - PubMed
Klingman 1985 {published data only}
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Klorman 1980 {published data only}
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Kolk 2000 {published data only}
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Krauss 1996 {unpublished data only}
    1. Krauss WJ. Videotape modelling and parent participation: Effects on reducing distress behavior in children undergoing immunization procedures [Doctoral dissertation]. California School of Professional Psychology, 1996.
Kuttner 1988 {published data only}
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Kwekkeboom 2003 {unpublished data only}
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Lawes 2008 {published data only}
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Lee 2013 {published data only}
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Lessi 2011 {published data only}
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Liossi 2007 {published data only}
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Lustman 1983 {published data only}
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MacLaren 2005 {published data only}
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MacLaren 2007 {published data only}
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Malone 1996 {published data only}
    1. Malone AB. The effects of live music on the distress of pediatric patients receiving intravenous starts, venipunctures, injections, and heel sticks. Journal of Music Therapy 1996;33(1):19-33.
Manimala 2000 {published data only}
    1. Manimala R, Blount RL, Cohen LL. The effects of parental reassurance versus distraction on child distress and coping during immunizations. Child Health Care 2000;29(3):161-77.
Manne 1990 {published data only}
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Manne 1994 {published data only}
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Marec‐Bérard 2009 {published data only}
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McCarthy 1998 {published data only}
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Megel 1998 {published data only}
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Melamed 1974 {published data only}
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Moadad 2016 {published data only}
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Myrvik 2009 {unpublished data only}
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Nilsson 2009 {published data only}
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O'Laughlin 1995 {published data only}
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Oberoi 2016 {published data only}
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Olsen 1991 {published data only}
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Ozdemir 2012 {published data only}
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Peretz 1999 {published data only}
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Posner 1998 {unpublished data only}
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Powers 1993 {published data only}
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Ramponi 2009 {published data only}
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Reeb 1997 {published data only}
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Schur 1986 {unpublished data only}
    1. Schur JM. Alleviating behavioral distress with music or lamaze pant-blow breathing in children undergoing bone marrow aspirations and lumbar punctures [Doctoral dissertation]. The University of Texas Health Science Center at Dallas, 1986.
Seiden 2014 {published data only}
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Shabanloei 2010 {published data only}
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References to other published versions of this review

Uman 2005
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