220 Participants Needed

Virtual Reality Therapy for Burns

Recruiting at 1 trial location
HX
Overseen ByHenry Xiang, MD, MPH, PhD, MBA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Nationwide Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12467

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.
See 3 more

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.
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Virtual reality as an intervention for adult burn patientsVirtual reality (VR) allows burn patients to engage in a virtual world and can provide patients with a distraction from pain.
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.
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 ...
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 ...
Efficacy of virtual reality in pediatric burn patientsOutcomes: Studies must report data on primary outcome: pain intensity. Studies reporting data on any secondary outcome were also included ...
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.
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 ...
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