Virtual Reality Therapy for Burns

(BURN-360 Trial)

Overseen By Alan D Rogers, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Mechanical ventilation, Intravenous sedation, Face burns, Resistant bacteria, Motion sickness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality (VR) can help manage pain and anxiety during dressing changes for burn patients. Participants will watch immersive VR videos to determine if this reduces their need for painkillers, such as opioids. The trial aims to help patients recover faster and avoid long-term dependence on pain medication. Individuals who have recently undergone skin graft surgery for burns and require hospital stays for dressing changes may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques without the constraints of traditional drug trials.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on using virtual reality to reduce the need for painkillers during dressing changes.

What prior data suggests that this virtual reality therapy is safe for burn patients?

Research has shown that using virtual reality (VR) during burn treatment can help manage pain. Studies have found that VR reduces pain levels and makes the experience less unpleasant for patients. In these studies, patients reported spending less time thinking about their pain while using VR.

The treatment is generally well-tolerated, with most patients experiencing no issues with the VR headset. There are no major reports of negative side effects from using VR in these situations, suggesting that VR is a safe option for pain relief during burn wound care.

For those considering joining a trial using VR for pain management, existing research suggests it is a safe and effective way to help reduce pain and anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using immersive VR video for burn treatment because it offers a unique way to manage pain without relying solely on medications. Traditional methods often depend on analgesics, which can have side effects and require careful dosing. VR therapy provides a distraction that can significantly reduce the perceived pain during dressing changes, potentially decreasing the need for additional medication. By engaging patients in a virtual environment, this method offers a novel, non-invasive approach to pain management, which could improve comfort and recovery experiences for burn patients.

What evidence suggests that this VR therapy is effective for reducing pain and anxiety during burn treatment?

This trial will compare virtual reality (VR) therapy with standard treatment during dressing changes for burn patients. Studies have shown that VR can effectively reduce pain and anxiety during these procedures. Research indicates that VR can lessen the pain experienced during wound care, making these procedures easier for patients. One study found that VR reduced pain in burn patients during both dressing changes and physical therapy. Another study showed that VR consistently lowered pain across multiple dressing sessions. By immersing patients in a computer-generated world, VR provides a distraction that helps them focus less on their pain and discomfort. Participants in the VR-360 group of this trial will experience this immersive therapy during dressing changes. ^{1 4 6 7 8}

Who Is on the Research Team?

Alan D Rogers, MD

Principal Investigator

SHSC

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are alert, can watch VR videos and answer questions. They must be in the hospital for at least two days of dressing changes after one skin graft surgery for burns but haven't had significant face, neck or scalp burns, resistant bacteria infections, communication issues, severe motion sickness history or need mechanical ventilation or IV sedation.

Inclusion Criteria

I am mentally alert and can watch videos and answer questions.

I will need to stay in the hospital for at least two days for dressing changes.

I am expected to have one skin graft surgery for my burn injury.

Exclusion Criteria

I have an infection caused by bacteria resistant to common antibiotics.

I am unable to communicate effectively.

I am currently receiving sedation through an IV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dressing changes with VR-360 distraction video to reduce pain and anxiety

2 days

2 visits (in-person)

Follow-up

Participants are monitored for opioid use and anxiety levels post-treatment

3 months

1 visit (in-person)

Long-term follow-up

Participants are assessed for opioid use and PTSD symptoms at 3 months post-procedure

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Immersive VR Video

Trial Overview

The study tests if immersive Virtual Reality (VR) during dressing changes post-skin graft surgery can reduce pain and anxiety. This could potentially lower the need for opioid painkillers. Participants will use VR headgear to view 360 videos created by researchers and rate their pain and anxiety before and after.

How Is the Trial Designed?

Group I: VR-360 group (VR-group) Experimental Treatment 1 Intervention

Patients will watch a VR-360 distraction video during dressing change. The patient will be asked or helped to wear the HMD write in full at the onset of a procedure and watch the VR-360 video during the dressing change procedure. When experiencing pain, the patient may indicate the need for further analgesic medication during the procedure, the patient will be asked to push a button in their hand that will trigger a light-based signal for the nurse to provide further analgesic medication. Should their hands both be involved in the burn injury, the patient will indicate the same verbally.

Group II: Control Group (standard treatment) Active Control 1 Intervention

The patients will receive standard treatment and will be instructed to use the same button to indicate their pain.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

A systematic review and meta-analysis of 30 studies involving 1,293 burn patients found that virtual reality (VR) significantly reduces pain severity during wound care procedures, with a strong effect size (SMD: -0.70).

Immersive VR interventions were particularly effective in decreasing pain intensity compared to control groups, while non-immersive VR did not show significant benefits, suggesting that immersive VR should be prioritized in burn care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality-Based Interventions on Pain During Wound Care in Burn Patients; a Systematic Review and Meta-Analysis. Norouzkhani, N., Chaghian Arani, R., Mehrabi, H., et al.[2022]

The study involving 11 adult burn patients suggested that using a low-cost VR system alongside pharmacological analgesia may help reduce pain and anxiety during physiotherapy, although the differences were not statistically significant.

Despite the lack of significant results, the VR system was deemed safe and could potentially enhance pain management strategies in burn treatment settings, indicating a promising area for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and potential effect of a low-cost virtual reality system on reducing pain and anxiety in adult burn injury patients during physiotherapy in a developing country. Morris, LD., Louw, QA., Crous, LC.[2019]

A systematic review of 10 studies involving pediatric patients with burn injuries found that virtual reality (VR) significantly reduces pain and anxiety during wound care procedures, with a moderate to large effect size (SMD=0.60).

The effectiveness of VR was consistent across studies, supporting its integration into traditional pain management protocols for children undergoing burn care, regardless of the specific VR content or delivery method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Virtual Reality Technology on Pain and Anxiety in Pediatric Burn Patients: A Systematic Review and Meta-Analysis. Smith, KL., Wang, Y., Colloca, L.[2022]

An 11-year-old burn patient experienced significant pain reduction during therapy when using inexpensive Oculus Rift Virtual Reality (VR) goggles, with pain intensity ratings dropping from severely painful to moderately painful.

This study suggests that immersive VR environments can be an effective and cost-efficient method for managing acute procedural pain in burn patients, warranting further research into its broader applications in pain control and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. Hoffman, HG., Meyer, WJ., Ramirez, M., et al.[2022]

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) 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) interventions significantly reduce pain during burn wound care procedures compared to standard care, with a moderate effect size (SMD = -0.49) and even greater effectiveness when immersive VR is used (SMD = -0.71).

While VR shows promise in alleviating pain, it does not significantly improve range of motion outcomes, indicating that further research is needed to fully understand its benefits and to standardize its use in medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality intervention as a support method during wound care and rehabilitation after burns: A systematic review and meta-analysis. Czech, O., Wrzeciono, A., Batalík, L., et al.[2022]

In a study involving four patients undergoing burn wound care, the use of virtual reality (VR) distraction significantly reduced the time spent thinking about pain and increased the enjoyment of the experience compared to standard care without VR.

Brain imaging showed that VR led to a relative decrease in cerebellar activation, suggesting that VR may alter brain activity related to pain perception, supporting its potential as an effective distraction analgesia tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of the Cerebellum in Pain Perception: A Brain SPECT Perfusion Study in Patients with Burn Injuries. Bermo, MS., Zacharias, C., Patterson, D., et al.[2021]

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]

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