VR-PAT During Home Burn Dressings - Multisite

A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition

This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.

Study Overview

• Status: Enrolling by invitation
• Conditions: Burns; Acute Pain; Pediatric ALL; Injuries; Procedural Pain
• Intervention / Treatment: Other: VR-PAT

Detailed Description

In this two-group randomized clinical trial, participants will be randomly assigned to either the VR-PAT intervention group or control group (standard distraction techniques available in the home). Participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Participants 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 (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Health & Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being treated for acute burn injury
• Age 6-17 years, inclusive
• Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit
• Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient)
• Patient and family caregivers can communicate (read and write) using English or Spanish
• Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change.

Exclusion Criteria:

• Any wounds that may interfere with study procedures
• 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, prisoners, or currently pregnant
• Suspected child abuse
• Families who do not have access to a VR compatible smartphone.

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: Intervention Group; Participants will be using the VR-PAT during burn dressings.	Other: VR-PAT; Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset; Other Names: Virtual Reality
No Intervention: Control Group; Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported pain	0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.	Immediately following each dressing change for one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported VR experience	0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.	Immediately following each dressing change for one week

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Parkland Health and Hospital System

Publications and helpful links

General Publications

• Lu A, Armstrong M, Alexander R, Vest E, Chang J, Zhu M, Xiang H. Trends in pediatric prescription-opioid overdoses in U.S. emergency departments from 2008-2020: An epidemiologic study of pediatric opioid overdose ED visits. PLoS One. 2024 Apr 17;19(4):e0299163. doi: 10.1371/journal.pone.0299163. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Virtual Reality; Burns; VR
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Pain, Procedural; Acute Pain; Burns
• Other Study ID Numbers: STUDY00002851

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
• product manufactured in and exported from the U.S.: No