Clinical trial NCT04544631: VR for Pediatric Burn Dressing Changes
Official title: Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Burns
Keywords: Pediatrics
Burns
Pain
Virtual Reality
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, three-group between subject randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.


Eligibility criteria: Inclusion Criteria:

* children age 6-17 years (inclusive)
* admitted or seen in the outpatient clinic for a burn injury
* spoke English as primary language

Exclusion Criteria:

* a severe burn on the face or head that prevented the utilization of the VR
* cognitive or motor impairment that prevented valid administration of study measures
* visual or hearing impairments that prevented interaction with the VR environment
* did not have a legal guardian present to give consent

Primary outcomes:
measure: Observed pain
timeFrame: During outpatient burn dressing change, on average lasting about 15 minutes.
measure: Patient self-reported pain
timeFrame: During outpatient burn dressing change, on average lasting about 15 minutes.
Secondary outcomes:
measure: VR experience self-reported by patient and parents
timeFrame: During outpatient burn dressing change, on average lasting about 15 minutes.
measure: Simulator sickness symptoms of patient
timeFrame: During outpatient burn dressing change, on average lasting about 15 minutes.
measure: Nurse reported feasibility of VR in clinical burn wound care
timeFrame: During outpatient burn dressing change, on average lasting about 15 minutes.
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Henry Xiang, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112082. doi: 10.1001/jamanetworkopen.2021.12082.
citation: Vest E, Armstrong M, Olbrecht VA, Thakkar RK, Fabia RB, Groner JI, Noffsinger D, Tram NK, Xiang H. Association of Pre-procedural Anxiety With Procedure-Related Pain During Outpatient Pediatric Burn Care: A Pilot Study. J Burn Care Res. 2023 May 2;44(3):610-617. doi: 10.1093/jbcr/irac108.
citation: Jain S, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Nelson E, Xiang H. Features of virtual reality impact effectiveness of VR pain alleviation therapeutics in pediatric burn patients: A randomized clinical trial. PLOS Digit Health. 2024 Jan 25;3(1):e0000440. doi: 10.1371/journal.pdig.0000440. eCollection 2024 Jan.
citation: Jones K, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Griffin B, Xiang H. Age and Sex Differences of Virtual Reality Pain Alleviation Therapeutic During Pediatric Burn Care: A Randomized Clinical Trial. J Med Ext Real. 2024 Jul 24;1(1):163-173. doi: 10.1089/jmxr.2024.0004. eCollection 2024 Jul.