Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials

      Objective

      To assess the efficacy and safety of a virtual reality distraction for needle pain in 2 common hospital settings: the emergency department (ED) and outpatient pathology (ie, outpatient laboratory). The control was standard of care (SOC) practice.

      Study design

      In 2 clinical trials, we randomized children aged 4-11 years undergoing venous needle procedures to virtual reality or SOC at 2 tertiary Australian hospitals. In the first study, we enrolled children in the ED requiring intravenous cannulation or venipuncture. In the second, we enrolled children in outpatient pathology requiring venipuncture. In the ED, 64 children were assigned to virtual reality and 59 to SOC. In pathology, 63 children were assigned to virtual reality and 68 to SOC; 2 children withdrew assent in the SOC arm, leaving 66. The primary endpoint was change from baseline pain between virtual reality and SOC on child-rated Faces Pain Scale-Revised.

      Results

      In the ED, there was no change in pain from baseline with SOC, whereas virtual reality produced a significant reduction in pain (between-group difference, −1.78; 95% CI, −3.24 to −0.317; P = .018). In pathology, both groups experienced an increase in pain from baseline, but this was significantly less in the virtual reality group (between-group difference, −1.39; 95% CI, −2.68 to −0.11; P = .034). Across both studies, 10 participants experienced minor adverse events, equally distributed between virtual reality/SOC; none required pharmacotherapy.

      Conclusions

      In children aged 4-11 years of age undergoing intravenous cannulation or venipuncture, virtual reality was efficacious in decreasing pain and was safe.

      Trial registration

      Australia and New Zealand Clinical Trial Registry: ACTRN12617000285358p

      Keywords

      Abbreviations:

      ED ( Emergency department), FPS-R ( Faces Pain Scale-Revised), MCID ( Minimally clinically important difference), SOC ( Standard of care)
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      References

        • Friedrichsdorf S.J.
        • Postier A.
        • Eull D.
        • Weidner C.
        • Foster L.
        • Gilbert M.
        • et al.
        Pain outcomes in a US children's hospital: a prospective cross-sectional survey.
        Hosp Pediatr. 2015; 5: 18-26
        • Shomaker K.
        • Dutton S.
        • Mark M.
        Pain prevalence and treatment patterns in a US Children's hospital.
        Hosp Pediatr. 2015; 5: 363-370
        • McMurtry C.M.
        • Pillai Riddell R.
        • Taddio A.
        • Racine N.
        • Asmundson G.J.G.
        • Noel M.
        • et al.
        Far from “just a poke”: common painful needle procedures and the development of needle fear.
        Clin J Pain. 2015; 31: S3-S11
        • Stinson J.
        • Yamada J.
        • Dickson A.
        • Lamba J.
        • Stevens B.
        Review of systematic reviews on acute procedural pain in children in the hospital setting.
        Pain Res Manag J Can Pain Soc. 2008; 13: 51-57
        • Brennan F.
        • Carr D.B.
        • Cousins M.
        Pain management: a fundamental human right.
        Anesth Analg. 2007; 105: 205-221
        • Friedrichsdorf S.J.
        • Eull D.
        • Weidner C.
        A Children's comfort promise: how can we do everything possible to prevent and treat pain in children using quality improvement strategies?.
        Paediatr Pain Lett. 2016; 18: 5
        • Birnie K.A.
        • Chambers C.T.
        • Fernandez C.V.
        • Forgeron P.A.
        • Latimer M.A.
        • McGrath P.J.
        • et al.
        Hospitalized children continue to report undertreated and preventable pain.
        Pain Res Manag. 2014; 19: 198-204
        • Gaskell S.
        Evidence-based guidelines for the management of invasive and/or distressing procedures with children.
        British Psychological Society, Leicester2010
        • Krauss B.S.
        • Calligaris L.
        • Green S.M.
        • Barbi E.
        Current concepts in management of pain in children in the emergency department.
        Lancet. 2016; 387: 83-92
        • Schulz K.F.
        CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
        Ann Intern Med. 2010; 152: 726
        • Boutron I.
        • Altman D.G.
        • Moher D.
        • Schulz K.F.
        • Ravaud P.
        • CONSORT NPT Group
        CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts.
        Ann Intern Med. 2017; 167: 40
        • National Health and Medical Research
        National statement on ethical conduct in human research (2007).
        National Health and Medical Research, 2015
        • Breivik H.
        • Borchgrevink P.C.
        • Allen S.M.
        • Rosseland L.A.
        • Romundstad L.
        • Breivik Hals E.K.
        • et al.
        Assessment of pain.
        Br J Anaesth. 2008; 101: 17-24
        • Beller E.M.
        • Gebski V.
        • Keech A.C.
        Randomisation in clinical trials.
        Med J Aust. 2002; 177: 4
        • Hicks C.L.
        • von Baeyer C.L.
        • Spafford P.A.
        • van Korlaar I.
        • Goodenough B.
        The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement.
        Pain. 2001; 93: 173-183
        • Tomlinson D.
        • von Baeyer C.L.
        • Stinson J.N.
        • Sung L.
        A systematic review of Faces Scales for the self-report of pain intensity in children.
        Pediatrics. 2010; 126: e1168-e1198
        • McGrath P.J.
        • Walco G.A.
        • Turk D.C.
        • Dworkin R.H.
        • Brown M.T.
        • Davidson K.
        • et al.
        Core Outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations.
        J Pain. 2008; 9: 771-783
        • Ersig A.L.
        • Kleiber C.
        • McCarthy A.M.
        • Hanrahan K.
        Validation of a clinically useful measure of children’s state anxiety before medical procedures.
        J Spec Pediatr Nurs. 2013; 18: 311-319
        • Yen K.
        • Riegert A.
        • Gorelick M.H.
        Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access.
        Pediatr Emerg Care. 2008; 24: 143-147
        • Faul F.
        • Erdfelder E.
        • Lang A.-G.
        • Buchner A.
        G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.
        Behav Res Methods. 2007; 39: 175-191
        • Migdal M.
        • Chudzynska-Pomianowska E.
        • Vause E.
        • Henry E.
        • Lazar J.
        Rapid, needle-free delivery of lidocaine for reducing the pain of venipuncture among pediatric subjects.
        Pediatrics. 2005; 115: e393-e398
        • Althouse A.D.
        Adjust for multiple comparisons? It's not that simple.
        Ann Thorac Surg. 2016; 101: 1644-1645
        • Vickers A.J.
        The use of percentage change from baseline as an outcome in a controlled trial is statistically inefficient: a simulation study.
        (BMC Med Res Methodol)
        • Vickers A.J.
        • Altman D.G.
        Statistics notes: analysing controlled trials with baseline and follow up measurements.
        BMJ. 2001; 323: 1123-1124
        • Braun V.
        • Clarke V.
        Using thematic analysis in psychology.
        Qual Res Psychol. 2006; 3: 77-101
        • Kennedy R.M.
        • Luhmann J.
        • Zempsky W.T.
        Clinical implications of unmanaged needle-insertion pain and distress in children.
        Pediatrics. 2008; 122: S130-S133
        • Walsh B.M.
        • Bartfield J.M.
        Survey of parental willingness to pay and willingness to stay for “painless” intravenous catheter placement.
        Pediatr Emerg Care. 2006; 22: 699-703
        • Matsangidou M.
        • Ang C.S.
        • Sakel M.
        Clinical utility of virtual reality in pain management: a comprehensive research review.
        Br J Neurosci Nurs. 2017; 13: 133-143
        • Garrett B.
        • Taverner T.
        • Masinde W.
        • Gromala D.
        • Shaw C.
        • Negraeff M.
        A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice.
        Clin J Pain. 2014; 30: 1089-1098
        • Kenney M.P.
        • Milling L.S.
        The effectiveness of virtual reality distraction for reducing pain: a meta-analysis.
        Psychol Conscious Theory Res Pract. 2016; 3: 199-210
        • Chan E.
        • Foster S.
        • Sambell R.
        • Leong P.
        Clinical efficacy of virtual reality for acute procedural pain management: a systematic review and meta-analysis.
        PLoS One. 2018; 13: e0200987
        • Dascal J.
        • Reid M.
        • IsHak W.W.
        • Spiegel B.
        • Recacho J.
        • Rosen B.
        • et al.
        Virtual reality and medical inpatients: a systematic review of randomized, controlled trials.
        Innov Clin Neurosci. 2017; 14: 14-21
        • Schwartz D.
        • Lellouch J.
        Explanatory and pragmatic attitudes in therapeutical trials.
        J Chronic Dis. 1967; 20: 637-648
        • Gold J.I.
        • Kim S.H.
        • Kant A.J.
        • Joseph M.H.
        • Rizzo A.S.
        Effectiveness of virtual reality for pediatric pain distraction during i.v. placement.
        Cyberpsychology Behav. 2006; 9: 207-212
        • Gershon J.
        • Zimand E.
        • Pickering M.
        • Rothbaum B.O.
        • Hodges L.
        A pilot and feasibility study of virtual reality as a distraction for children with cancer.
        J Am Acad Child Adolesc Psychiatry. 2004; 43: 1243-1249
        • Wolitzky K.
        • Fivush R.
        • Zimand E.
        • Hodges L.
        • Rothbaum B.O.
        Effectiveness of virtual reality distraction during a painful medical procedure in pediatric oncology patients.
        Psychol Health. 2005; 20: 817-824
        • Gold J.I.
        • Mahrer N.E.
        Is virtual reality ready for prime time in the medical space? A randomized control trial of pediatric virtual reality for acute procedural pain management.
        (J Pediatr Psychol)
        • Bienvenu O.J.
        • Eaton W.W.
        The epidemiology of blood-injection-injury phobia.
        Psychol Med. 1998; 28: 1129-1136
        • Lander J.A.
        • Weltman B.J.
        • So S.S.
        EMLA and Amethocaine for reduction of children's pain associated with needle insertion. The Cochrane Collaboration. Cochrane Database of Systematic Reviews [Internet].
        John Wiley & Sons, Ltd, Chichester, UK2006
        • Kearl Y.L.
        • 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?.
        J Pediatr Nurs. 2015; 30: 829-833
        • Uman L.S.
        • Birnie K.A.
        • Noel M.
        • Parker J.A.
        • Chambers C.T.
        • McGrath P.J.
        • et al.
        Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Pain, Palliative and Supportive Care Group. Cochrane Database Syst Rev [Internet].
        • Birnie K.A.
        • Noel M.
        • Parker J.A.
        • Chambers C.T.
        • Uman L.S.
        • Kisely S.R.
        • et al.
        Systematic Review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents.
        J Pediatr Psychol. 2014; 39: 783-808
        • McCaul K.D.
        • Malott J.M.
        Distraction and coping with pain.
        Psychol Bull. 1984; 95: 516-533
        • Gold J.I.
        • Belmont K.A.
        • Thomas D.A.
        The neurobiology of virtual reality pain attenuation.
        Cyberpsychol Behav. 2007; 10: 536-544
        • Beaton D.E.
        • Boers M.
        • Wells G.A.
        Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research.
        Curr Opin Rheumatol. 2002; 14
        • Cook C.E.
        Clinimetrics corner: the Minimal Clinically Important Change Score (MCID): a necessary pretense.
        J Man Manip Ther. 2008; 16: 82E-83E
        • Copay A.G.
        • Subach B.R.
        • Glassman S.D.
        • Polly D.W.
        • Schuler T.C.
        Understanding the minimum clinically important difference: a review of concepts and methods.
        Spine J. 2007; 7: 541-546
        • Angst F.
        • Aeschlimann A.
        • Angst J.
        The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies.
        J Clin Epidemiol. 2017; 82: 128-136
        • Voepel-Lewis T.
        • Burke C.N.
        • Jeffreys N.
        • Malviya S.
        • Tait A.R.
        Do 0–10 numeric rating scores translate into clinically meaningful pain measures for children?.
        Anesth Analg. 2011; 112: 415-421
        • Bailey B.
        • Daoust R.
        • Doyon-Trottier E.
        • Dauphin-Pierre S.
        • Gravel J.
        Validation and properties of the verbal numeric scale in children with acute pain.
        Pain. 2010; 149: 216-221
        • Bulloch B.
        • Tenenbein M.
        Assessment of clinically significant changes in acute pain in children.
        Acad Emerg Med. 2002; 9: 199-202
        • Tsze D.S.
        • Hirschfeld G.
        • von Baeyer C.L.
        • Bulloch B.
        • Dayan P.S.
        Clinically significant differences in acute pain measured on self-report pain scales in children.
        Acad Emerg Med. 2015; 22: 415-422
        • Day S.J.
        Statistics notes: blinding in clinical trials and other studies.
        BMJ. 2000; 321: 504
        • Schulz K.F.
        • Grimes D.A.
        Multiplicity in randomised trials I: endpoints and treatments.
        Lancet. 2005; 365: 1591-1595