VR for Burn Dressing Changes at Home

Phase 2

Completed

• Conditions: Burns; Acute Pain; Procedural Pain
• Interventions: Device: VR-PAT

• Registration Number: NCT04548635
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-09-05
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-14
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR-PAT	VR-PAT	Virtual Reality administered during burn dressing changes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States