What side effects are associated with this type of intervention?

Common treatments for pain that involve distraction and pain modulation, such as remote electrical neuromodulation, transcranial magnetic stimulation (TMS), noninvasive vagus nerve stimulation (nVNS), and Scrambler therapy, generally have mild side effects. Remote electrical neuromodulation may cause a warm sensation, numbness, redness, itching, tingling, muscle spasm, and localized pain. TMS can potentially trigger seizures in patients with epilepsy but otherwise has no serious adverse events. nVNS and Scrambler therapy are generally well-tolerated, with Scrambler therapy showing no significant adverse effects in studies. Overall, these treatments are considered safe with minimal side effects.

What prior FDA approvals exist?

The FDA has approved several non-pharmacological treatments for pain management that are similar to Virtual Reality (VR) in their approach to distraction and pain modulation. These include remote electrical neuromodulation (REN), transcranial magnetic stimulation (TMS), and noninvasive vagus nerve stimulation (nVNS), all of which have demonstrated efficacy in clinical trials for acute migraine treatment. While VR itself is not specifically mentioned as FDA-approved, it is being studied as a promising adjunctive technique for pain management in burn patients and cancer pain.

What other types of research exist?

Promising, novel alternatives to Virtual Reality for pain management in 2024 include: 1) Game-based digital therapeutics, which have been FDA-approved for improving attention and potentially modulating pain perception. 2) Trigeminal nerve stimulation, which has shown efficacy in pilot studies for conditions like ADHD and may have applications in pain management. 3) Biofeedback-assisted relaxation, which has demonstrated effectiveness in reducing chronic pain in cancer patients. 4) Electroencephalogram-based neurofeedback, which has potential benefits for chemotherapy-induced peripheral neuropathy and may be applicable to other pain conditions.

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Virtual Reality for Pain Management in Burn Patients

N/A

Recruiting

Led By JoAnn Difede, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient does not require conscious sedation such as ketamine for staple removal or wound dressing changes

Awake, alert, ambulatory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of hospitalization to last day of hospitalization (approximately 15 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using VR headsets can help reduce pain for adult burn patients by distracting them with virtual experiences. Virtual reality (VR) has been shown to reduce pain in various medical procedures, including burn wound care.

Who is the study for?

This trial is for burn patients aged 8 and older at New York Presbyterian who are awake, alert, can move on their own, have burns covering less than 15% of their body, and can consent to the study. It's not for those with certain cognitive or psychotic disorders or current opioid abuse.

What is being tested?

The study tests if Virtual Reality (VR) can help manage pain during procedures like wound dressing changes in addition to standard care with opioids. Patients will be split into two groups: one receives VR plus standard care; the other only gets standard care.

What are the potential side effects?

Since VR is non-invasive, side effects may include discomfort from wearing the headset or motion sickness. Opioids used as part of standard care can cause drowsiness, nausea, constipation, addiction risk and other known side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't need strong sedation for minor procedures like staple removal.

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I am awake, alert, and able to walk.

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I am at least 8 years old.

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My burn affects less than 15% of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of hospitalization to last day of hospitalization (approximately 15 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of hospitalization to last day of hospitalization (approximately 15 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of hospitalization to last day of hospitalization (approximately 15 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain

Secondary study objectives

Change in Anxiety Symptoms

Change in Depressive Symptoms

Change in anxiolytics dose

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual RealityExperimental Treatment1 Intervention

Virtual reality-enhanced distraction using a portable head mounted display during panful events (such as wound dressing changes or physical therapy sessions) in addition to standard of care.

Group II: Treatment as UsualActive Control1 Intervention

Standard of care during painful event (such as wound dressing changes or physical therapy sessions).

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common pain treatments, such as Virtual Reality (VR) distraction, work by engaging cognitive distraction and activating descending pain modulation pathways. These mechanisms help reduce the perception of pain by diverting the patient's attention away from the pain and altering pain processing in the brain. This is particularly important for pain patients as it provides a non-pharmacologic option that can be used alongside or instead of medications, potentially reducing reliance on opioids and minimizing associated side effects.

The Use of Virtual Reality in Back Pain Rehabilitation: A Systematic Review and Meta-Analysis.The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments.