VR-PAT for Procedural Pain

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

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Vision, hearing, cognitive impairments, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain during burn dressing changes using virtual reality (VR). The researchers aim to determine if playing a VR game reduces pain more effectively than standard distraction techniques. Participants will wear a VR headset and a device called fNIRS to measure brain activity during dressing changes. Children and teens aged 6 to 17, who are receiving treatment for acute burns and need daily dressing changes over three days, may be suitable candidates, particularly if they and their caregivers can communicate in English. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that this VR-PAT is safe for use during burn dressing changes?

Research has shown that using virtual reality (VR) to manage pain is generally safe for both adults and children. For example, a review of studies found that adults using VR for short-term pain relief tolerated it well, with no major safety issues. Another study focused on children found that VR could reduce pain and anxiety during medical procedures without causing significant side effects.

Further research on using VR for long-term pain, such as chronic muscle and joint pain, also suggests it is a safe option. These findings indicate that VR treatments, like VR-PAT, are usually well-received by users and have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VR-PAT because it offers a new way to manage procedural pain during burn dressing changes using virtual reality. Unlike traditional pain management options, which often rely on medications like opioids or distraction techniques, VR-PAT immerses patients in an interactive virtual environment. This method not only provides a unique and engaging distraction but also potentially reduces the need for pain medications, minimizing their side effects. The use of a VR headset, like the Pico Neo 3 Pro Eye, represents a novel delivery method that could transform pain management, making it more engaging and effective for patients.

What evidence suggests that VR-PAT is effective for procedural pain?

Research has shown that virtual reality (VR) can significantly reduce pain during burn dressing changes. Several studies have found that VR tools, such as VR-PAT, lower pain levels compared to standard care methods. In this trial, participants in the VR-PAT arm will wear the Pico Neo 3 Pro Eye headset and actively play the VR-PAT game during their clinically scheduled burn dressing change. One study reported that patients using VR experienced less pain during the procedure, suggesting VR as an effective pain management tool. Another study found both observed and self-reported pain decreased with VR use. These findings support the potential of VR-PAT to offer significant pain relief for burn patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Henry Xiang, MD, MPH, PhD, MBA

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 6-17 with acute burn injuries being treated at NCH burn unit, who need daily dressing changes over three days. Participants must be able to communicate in English. It's not suitable for those with motion sickness, seizures, dizziness from visual auras, or cognitive impairments that prevent study participation.

Inclusion Criteria

Patient and family caregivers can communicate (read and write) using English

I am currently receiving treatment for a recent burn injury.

I am being treated in the NCH burn unit.

Exclusion Criteria

I do not have vision, hearing, or cognitive issues that would prevent me from participating in study tasks.

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

Minors in foster care, prisoners, or currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo burn dressing changes while brain activity is monitored using fNIRS, with some participants engaging in VR-based interventions

5 days

Daily visits during the study period

Follow-up

Participants are monitored for changes in brain activity and self-reported pain and anxiety levels after the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• VR-PAT

Trial Overview

The study tests how well virtual reality (VR) can help manage pain during burn dressing changes by using functional near-infrared spectroscopy (fNIRS) to track brain signals and identify pain biomarkers.

How Is the Trial Designed?

Group I: VR-PAT Experimental Treatment 1 Intervention

Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game while also wearing the fNIRS, during their clinically scheduled burn dressing change.

Group II: Control Active Control 1 Intervention

Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Published Research Related to This Trial

In a study involving 30 participants with chronic pain, a virtual reality application called Cool! significantly reduced pain levels, with a 33% decrease from pre-session to post-session and a remarkable 60% reduction during the session.

All participants experienced some level of pain relief during the VR session, and 33% reported complete pain relief, suggesting that VR could be a promising non-opioid treatment option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Virtual Reality on Chronic Pain. Jones, T., Moore, T., Choo, J.[2022]

A novel virtual reality neuroscience-based therapy (VRNT) significantly reduced pain intensity and interference in 31 participants with chronic back pain compared to usual care, with effects lasting for at least two weeks after treatment.

VRNT not only improved pain-related outcomes but also enhanced overall functioning by potentially altering brain networks associated with pain, as indicated by MRI findings showing changes in connectivity and white matter integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. Čeko, M., Baeuerle, T., Webster, L., et al.[2023]

Virtual Reality (VR) shows promise as a noninvasive therapy for both acute and chronic pain, potentially offering an alternative to traditional analgesics that often have side effects or are insufficient for chronic pain management.

Mechanisms of pain relief through VR include distraction and cognitive behavioral changes, with immersive experiences enhancing effectiveness, making it a viable option for conditions like complex regional pain syndrome and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. Lindner, S., Latoschik, ME., Rittner, H.[2020]

A review of 11 controlled studies indicates that virtual reality (VR) distraction is effective in reducing both experimental pain and discomfort during burn injury care.

More advanced VR technology that fully immerses users in a virtual environment tends to provide greater pain relief, suggesting that VR could be a valuable tool for clinicians managing various pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality distraction for pain reduction: a systematic review. Malloy, KM., Milling, LS.[2022]

Citations

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