VR for Burn Dressing Changes at Home

Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management

This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.

Study Overview

• Status: Completed
• Conditions: Burns; Acute Pain; Procedural Pain
• Intervention / Treatment: Device: VR-PAT

Detailed Description

Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• pediatric patients age 5-17 years (inclusive)
• receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution
• have a dressing that requires daily changes at home for at least one week
• can communicate orally

Exclusion Criteria:

• any wounds that may interfere with study procedures (i.e. face)
• vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
• history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
• minors in foster care
• suspected child abuse
• unable to communicate in English
• families who do not have access to a smartphone (due to the VR-PAT game requirements)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-PAT; Virtual Reality administered during burn dressing changes	Device: VR-PAT; Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset; Other Names: Virtual Reality
No Intervention: Control; Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment during dressing changes.	1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.	15-30 minutes during daily burn dressing changes for up to 7 days.
Observed VR experience.	caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.	Daily for 15-30 minutes burn dressing change for up to 7 days.
Self-reported VR experience.	1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.	Daily for 15-30 minutes burn dressing change for up to 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burn-related medications	caregiver-reported name and dosage of medication provided for burn-related pain	Daily for burn dressing change for up to 7 days.

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Collaborators: Ohio Department of Public Safety

Publications and helpful links

General Publications

• Armstrong M, Lun J, Groner JI, Thakkar RK, Fabia R, Noffsinger D, Ni A, Keesari R, Xiang H. Mobile phone virtual reality game for pediatric home burn dressing pain management: a randomized feasibility clinical trial. Pilot Feasibility Stud. 2022 Aug 18;8(1):186. doi: 10.1186/s40814-022-01150-9.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): June 18, 2021
• Study Completion (Actual): June 18, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Virtual Reality; Burns; VR; Dressing Changes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Burns; Acute Pain; Pain, Procedural
• Other Study ID Numbers: STUDY00000450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No