Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials Evelyn Chan, MBBS, MSc, DCH 1,2 , Michael Hovenden, BASc, MBBS 3 , Emma Ramage, BN 4 , Norman Ling, MD 5 , Jeanette H. Pham, BPharm, MD 5 , Ayesha Rahim 3 , Connie Lam 3 , Linly Liu 3 , Samantha Foster 3 , Ryan Sambell 3 , Kasthoori Jeyachanthiran, BSc 6 , Catherine Crock, MBBS 7 , Amanda Stock, MBBS 8 , Sandy M. Hopper, MBBS 8,9 , Simon Cohen, BSc, MBCHB 10 , Andrew Davidson, MBBS, MD, GradDipBioEpi 6 , Karin Plummer, MS 6 , Erin Mills, MBBS 4 , Simon S. Craig, MBBS, MPHE, MPH 3,4 , Gary Deng, BEcon, MEcon, PhD 11 , and Paul Leong, MBBS, MPHTM 3,12 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. (J Pediatr 2019;-:1-8). Trial registration Australia and New Zealand Clinical Trial Registry: ACTRN12617000285358p P ediatric needle procedures, predominantly venipuncture and intrave- nous cannulation, are the most common cause of pain in US children’s hospitals. 1,2 Despite the repeated identification of pediatric needle pain as a priority, this remains undermanaged. 3-7 The recommended approach to pediatric procedural pain integrates psychological, physical, and pharmacological elements. 6,8 However, the commonplace strategies of topical local anesthetic or coolant preparations target only nociception. 2 These strategies do not address anxiety, a key driver of noncooperation, which encumbers needle procedure performance. 9 Non- pharmacological interventions to ameliorate anxiety are thus central to facilitate needle interventions, but are inconsistently applied. 1,2,6 Virtual reality is an interactive, 3-dimensional, computer-simulated environment accessed through a head-mounted device, precluding the real-world view. We postulated that virtual reality distraction would be a useful nonpharmacological intervention in hospital-based needle procedures for pediatric patients. From the 1 General Pediatrics, Monash Children’s Hospital, Clayton; 2 General Medicine, Royal Children’s Hospital, Parkville; 3 School of Clinical Sciences, Monash University and Monash Health, Clayton; 4 Pediatric Emergency Department, Monash Medical Centre, Clayton; 5 Melbourne Medical School, University of Melbourne, Parkville; 6 Anaesthesia and Pain Management Research Group, Murdoch Children’s Research Institute, Parkville; 7 School of Psychology, Centre for Social and Early Emotional Development, Faculty of Health, Deakin University, Geelong; 8 Emergency Department, Royal Children’s Hospital, Parkville; 9 Murdoch Children’s Research Institute, Parkville; 10 Pain Management, Monash Children’s Hospital, Clayton; 11 DataConnect, Melbourne; and 12 Monash Lung & Sleep, Monash Medical Centre, Clayton, Victoria, Australia Supported by the Australian Federal Government Department of Industry,Innovation and Science (ICG000042). The study funder and supporting bodies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manu- script; or decision to submit the manuscript for publica- tion. E.C. and P.L. hold shares in Smileyscope Pty Ltd holding intellectual property arising from this study, which includes a patent entitled “virtual reality appa- ratus.” The other authors declare no conflicts of interest. Portions of this study were presented at the Australian Health Informatics Conference, July 30, 2018, Sydney, Australia; the Australasian College for Emergency Medi- cine Annual Scientific Meeting, November 21, 2018; and The Australian Pain Society on April 7, 2019 in the Gold Coast, Australia. 0022-3476/$ - see front matter. ª2019 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jpeds.2019.02.034 ED Emergency department FPS-R Faces Pain Scale-Revised MCID Minimally clinically important difference SOC Standard of care 1 ORIGINAL ARTICLES