VR-PAT for Procedural Pain

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 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.12345

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.678910

Who Is on the Research Team?

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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.
See 2 more

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
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: VR-PATExperimental Treatment1 Intervention
Group II: ControlActive 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+

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

Citations

Effect of Virtual Reality-Based Interventions on Pain During ...(2019) showed that using of VR intervention significantly reduced the pain of burn wound debridement, while another study by Konstantatos et al. (2009) found ...
Efficacy of virtual reality in pediatric burn patientsAnalysis of the primary outcome showed that VR intervention significantly reduced pain intensity compared to standard care, with a pooled ...
Efficacy of Smartphone Active and Passive Virtual Reality ...The smartphone VR-PAT showed efficacy in reducing observed and patient self-reported pain during burn dressing changes. Patients and their ...
Effect of virtual reality on pain during burn dressing in ...They found that adjuvant full immersive VR significantly reduces the pain experienced during dressing changes in children and adolescents with burns (Lauwens et ...
Pilot randomized clinical trial of virtual reality pain ...We hypothesized that VR-PAT would decrease self-reported pain intensity among inpatient adult burn dressing changes. Findings and lessons from ...
A Systematic Review of Virtual Reality Therapeutics for ...The purpose of this systematic review is to examine the delivery and clinical efficacy of VR therapeutics for acute pain management in adults.
Systematic Review and Meta-analysis of Virtual Reality in ...This meta-analysis is the first to collate evidence on the effectiveness of VR on reducing pain and anxiety in pediatric patients undergoing medical procedures.
Virtual reality as a treatment for chronic musculoskeletal ...There is growing evidence that VR is an efficient and safe option for treating chronic musculoskeletal pain, suggesting it could become part of multimodal ...
Using Virtual Reality Exposure Therapy in Pain ManagementVR is a feasible alternative therapy for both juveniles and adults in pain management, and it has a greater potential for juveniles.
Telehealth virtual reality intervention reduces chronic pain ...In a 5-week crossover trial, we compared VR to matched audio content control in individuals with chronic pain. VR significantly reduced pain intensity, anxiety ...
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