Virtual Reality Therapy for Burns

Enrolling by invitation at 1 trial location

Overseen By Henry Xiang, MD, MPH, PhD, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Vision impairments, Seizure disorder, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of smartphone-based Virtual Reality Pain Alleviation Therapy (VR-PAT) in reducing pain during at-home burn dressing changes. The goal is to determine if VR-PAT helps children feel less pain compared to those who do not use it. Children with a burn injury requiring daily dressing changes at home may qualify if they experienced moderate pain during their most recent change.

As an unphased trial, this study provides a unique opportunity for children to potentially experience reduced pain through innovative technology.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this Virtual Reality Therapy is safe for children with burn injuries?

Research has shown that virtual reality (VR) can help reduce pain during burn care. Studies have found that using VR as a distraction lessens the intensity of pain and diverts patients' attention from it. In earlier research, patients using VR reported experiencing less pain during treatments like bandage changes.

VR treatments have been used in burn recovery and have improved quality of life. No known physical risks are associated with using VR. Therefore, VR-PAT, the VR therapy under study, appears to be a safe way to manage pain for burn patients during recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Pain Alleviation Therapy (VR-PAT) for burn care because it offers a novel way to manage pain during dressing changes. Unlike traditional pain management methods, which often rely on medications like opioids or non-drug distractions, VR-PAT uses immersive virtual reality experiences to divert the patient's attention away from the painful procedure. This non-invasive, drug-free approach not only reduces the need for painkillers but also minimizes the risk of side effects associated with them. By providing a more engaging and potentially more effective distraction, VR-PAT could significantly improve the pain management experience for burn patients.

What evidence suggests that VR-PAT is effective for pain distraction during burn dressing changes?

Research has shown that virtual reality (VR) can help reduce pain for burn patients. In this trial, participants in the intervention group will use VR-PAT during burn dressings. Studies have found that VR distracts patients from their pain, which is especially helpful during painful procedures like changing bandages. For example, VR significantly lowered pain levels during treatments. A review of several studies also found that VR can lessen the intensity of pain and reduce the time patients spend thinking about it. In children with burns, VR has shown promising results in lowering pain during care. Overall, VR is a promising tool for easing pain in burn patients. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 6-17 with burn injuries who need daily dressing changes at home and experience moderate to severe pain. They must be able to communicate in English or Spanish, not have impairments that affect study participation, and have access to a VR-compatible smartphone.

Inclusion Criteria

I and my family caregivers can communicate in English or Spanish.

I need daily dressing changes for a week after my first outpatient visit or hospital discharge.

I am getting my first dressing change as an outpatient or being discharged from the burn unit.

Exclusion Criteria

I have a history of motion sickness, seizures, dizziness, or migraines triggered by visual changes.

There is reason to believe that a child has been mistreated or harmed.

You don't have a smartphone that works with VR technology.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants perform daily burn dressing changes with or without VR-PAT for pain management

1 week

Daily at-home dressing changes

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VR-PAT

Trial Overview

The study tests if using Virtual Reality Pain Alleviation Therapy (VR-PAT) on a smartphone can help reduce pain during at-home burn dressing changes for kids with burns, compared to those not using VR-PAT.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants will be using the VR-PAT during burn dressings.

Group II: Control Group Active Control 1 Intervention

Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Parkland Health and Hospital System

Collaborator

Trials

20

Recruited

99,300+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

In a study of 39 adults with burn injuries, immersive virtual reality (VR) significantly reduced pain scores during physical therapy sessions, with reductions of 27% in worst pain, 37% in time spent thinking about pain, and 31% in pain unpleasantness compared to standard therapy without VR.

The use of VR did not negatively impact the range of motion (ROM) during therapy, and 97% of patients reported only zero to mild nausea, indicating that VR is a safe and effective nonpharmacologic option for pain management in postburn rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of virtual reality on pain and range of motion in adults with burn injuries. Carrougher, GJ., Hoffman, HG., Nakamura, D., et al.[2021]

Virtual reality (VR) can effectively reduce pain during burn care, but implementing it in a clinical setting requires a significant time commitment from staff, averaging 59 minutes per session for setup, instruction, therapy, and cleaning.

The lack of on-site technical support for VR equipment poses challenges, making it difficult for smaller burn centers to allocate the necessary resources for a VR program, highlighting the need for further research to evaluate the cost-effectiveness of VR in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: feasibility of implementation in a regional burn center. Markus, LA., Willems, KE., Maruna, CC., et al.[2019]

Immersive virtual reality (VR) distraction significantly reduces pain in burn patients undergoing passive range-of-motion physical therapy, with reductions of 20% in worst pain intensity and 26% in pain unpleasantness when compared to standard analgesic treatment alone.

The use of VR distraction is safe, with only 15% of patients experiencing mild nausea, and it is effective regardless of patient factors such as age, sex, or size of burn injury, making it a valuable nonpharmacologic adjunct to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Sharar, SR., Carrougher, GJ., Nakamura, D., et al.[2008]

Virtual Reality (VR) significantly reduces pain in burn injury patients during wound dressing changes and physiotherapy when used alongside pharmacologic analgesics, based on a systematic review of nine studies.

The evidence for VR's effectiveness in reducing anxiety during these procedures is less clear, indicating a need for further research to explore its potential benefits in managing anxiety for burn patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality on reducing pain and anxiety in burn injury patients: a systematic review. Morris, LD., Louw, QA., Grimmer-Somers, K.[2022]

Virtual reality (VR) rehabilitation significantly improves quality of life and work performance in burn patients, with a notable increase in range of motion (ROM) of joints (SMD=0.72) compared to usual rehabilitation methods.

VR interventions effectively reduce various aspects of pain (intensity, affective, and cognitive components) and lower anxiety levels during treatment, while also making rehabilitation more enjoyable, although they do not significantly enhance hand grip or pinch strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality in Burn Rehabilitation: A Systematic Review and Meta-analysis. Lan, X., Tan, Z., Zhou, T., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11924071/

Virtual reality as an intervention for adult burn patients

Virtual reality (VR) allows burn patients to engage in a virtual world and can provide patients with a distraction from pain.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0003999322005937

Use of Virtual Reality in Burn Rehabilitation: A Systematic ...

VR-based burn rehabilitation significantly improves the QOL and work performance of burn patients, significantly increases the ROM gain of the tested joints.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9410425/

A Systematic Review of the Effectiveness of Virtual Reality ...

The use of virtual-reality games significantly reduced pain scores during physiotherapy and occupational therapy treatments as well as in nursing care. The ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1524904224001000

Effects of Virtual Reality on Analgesia in Wound Care and ...

The results of this meta-analysis indicate that VR can effectively reduce worst pain intensity, pain unpleasantness intensity, and time spent thinking about ...

5.

frontiersin.org

frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2025.1651695/full

Efficacy of virtual reality in pediatric burn patients

Outcomes: Studies must report data on primary outcome: pain intensity. Studies reporting data on any secondary outcome were also included ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9676699/

Effect of Virtual Reality-Based Interventions on Pain During ...

This systematic review and meta-analysis aimed to examine the effect of virtual reality (VR)-based interventions on pain during wound care in burn patients.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06596837

Virtual Reality and Coping with Procedural Pain in Burn ...

The main aim of the project is to reduce the feeling of procedural pain (when changing bandages) in burn patients through a developed and pilot-verified ...