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

4 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).

Will I have to stop taking my current medications?

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

How does the VR-PAT treatment differ from other treatments for procedural pain?

VR-PAT is unique because it uses virtual reality (VR) to manage pain by immersing patients in a virtual environment, which can distract them from pain and alter their perception of it. Unlike traditional pain treatments that may rely on medications, VR-PAT leverages immersive technology to engage cognitive and emotional processes, potentially leading to significant and lasting pain relief without the side effects associated with drugs. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment VR-PAT for procedural pain?

Research shows that virtual reality (VR) can effectively reduce pain and anxiety during medical procedures. Studies have found that VR distraction helps decrease pain in children during needle procedures and in adults during awake surgeries, suggesting VR-PAT might also be effective for procedural pain. ^{5 6 7 8 9}

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

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]

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]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality distraction for pain reduction: a systematic review. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Analgesia During Venipuncture in Pediatric Patients With Onco-Hematological Diseases. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Virtual reality hypnosis for pain associated with recovery from physical trauma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Impact of Virtual Reality on Chronic Pain. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

VR for Pain Relief. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The neurobiology of virtual reality pain attenuation. [2022]

9. United States 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. [2023]