Virtual Reality Therapy for Burns

Recruiting 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

220 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment VR-PAT for burns?

Research shows that virtual reality (VR) can help reduce pain and anxiety in burn patients during wound care and physical therapy, making it a promising tool for improving their rehabilitation experience. ^{1 2 3 4 5}

Is virtual reality therapy safe for use in humans?

Virtual reality therapy has been shown to be a safe method for reducing pain in burn patients, with most patients experiencing zero to mild nausea. It is considered a safe, non-drug option for pain management during burn care. ^{3 5 6 7 8}

How does virtual reality therapy differ from other treatments for burns?

Virtual reality therapy for burns is unique because it uses immersive technology to distract patients from pain during rehabilitation and physical therapy, unlike traditional treatments that primarily rely on medications for pain relief. This approach not only helps in reducing pain and anxiety but also improves functional recovery, especially in burned hands, making it a novel adjunctive treatment option. ^{3 4 5 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual reality analgesia for burn joint flexibility: A randomized controlled trial. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality: feasibility of implementation in a regional burn center. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality in Burn Rehabilitation: A Systematic Review and Meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality on reducing pain and anxiety in burn injury patients: a systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effect of virtual reality on pain and range of motion in adults with burn injuries. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: Lessons learned. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality-Based Rehabilitation on Burned Hands: A Prospective, Randomized, Single-Blind Study. [2020]