VR for Pediatric Burn Dressing Changes

NCT04544631 | Completed

• 1 other identifier: IRB16-00444
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Burns

Keywords

Pediatrics; Burns; Pain; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Observed pain

  Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain.

  During outpatient burn dressing change, on average lasting about 15 minutes.

• Patient self-reported pain

  Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.

  During outpatient burn dressing change, on average lasting about 15 minutes.

Secondary Outcomes (3)

• VR experience self-reported by patient and parents

  During outpatient burn dressing change, on average lasting about 15 minutes.

• Simulator sickness symptoms of patient

  During outpatient burn dressing change, on average lasting about 15 minutes.

• Nurse reported feasibility of VR in clinical burn wound care

  During outpatient burn dressing change, on average lasting about 15 minutes.

Study Arms (3)

Active VR

EXPERIMENTAL

Participants in the active VR group played a virtual reality game entitled "Virtual River Cruise". In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced "cooling" experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure.

Other: Virtual reality game as adjunctive pain management tool

Passive VR

EXPERIMENTAL

Participants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game.

Other: Virtual reality game as adjunctive pain management tool

Standard Care Control

NO INTERVENTION

Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking.

Interventions

Virtual reality game as adjunctive pain management tool OTHER

A smart phone virtual reality-based pain alleviation tool (VR-PAT).

Active VR; Passive VR

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Related Publications (4)

• 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.

  PMID: 34152420 RESULT

• 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.

  PMID: 35913793 RESULT

• 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.

  PMID: 38271320 RESULT

• 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.

  PMID: 39091668 RESULT

MeSH Terms

Conditions

Pain; Burns

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Henry Xiang, MD, MPH, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers and nurses did not know the group assignment until immediately prior to intervention. Following the dressing change procedure, a second researcher, blinded to the group assignment, asked participants a post-assessment that included questions about child and guardian perceived pain and subjective VR experience.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Center Director

Model Details: A prospective, three-group between subject randomized controlled trial

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 10, 2020
• Study Start: December 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: March 3, 2019
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share