VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

NCT06303687 | Not Yet Recruiting

• 1 other identifier: STUDY00003496
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Pain; Pediatric ALL; Procedural Pain; Burns

Keywords

Virtual Reality; VR; fNIRS; Pain; Biomarker; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Change in brain activity

  Mean change of hemoglobin oxygen (HBO2) concentration between VR and Control as detected by fNIRS.

  Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)

Secondary Outcomes (3)

• Procedural pain during burn dressing changes

  Assessed within 15 minutes immediately after the burn dressing change about pain experienced during the procedure

• Change in procedural anxiety

  Assessed at 3 time points (30 minutes prior to procedure, immediately prior to procedure, and within 15 minutes immediately following the procedure) for each dressing change

• Self-reported VR experience

  Within 15 minutes immediately following burn dressing change when in VR-PAT group

Study Arms (2)

VR-PAT

EXPERIMENTAL

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.

Other: VR-PAT

Control

NO INTERVENTION

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

Interventions

VR-PAT OTHER

Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device

Also known as: Virtual Reality

VR-PAT

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being treated for acute burn injury
• Age 6-17 years, inclusive
• Admitted to NCH burn unit for treatment
• Have a dressing that requires daily changes over 3 days
• Patient and family caregivers can communicate (read and write) using English

You may not qualify if:

• Any wounds that may interfere with study procedures
• Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
• History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
• Minors in foster care, prisoners, or currently pregnant
• Suspected child abuse
• Unable to communicate in English

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Acute Pain; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pain, Procedural; Burns; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Wounds and Injuries

Study Officials

• Henry Xiang, MD, MPH, PhD, MBA

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Xiang, MD, MPH, PhD, MBA

CONTACT

614-355-5893; Henry.Xiang@NationwideChildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Center Director

Model Details: Participants will be randomly assigned to either the intervention (fNIRS and VR-PAT) or the control (fNIRS and standard of care) at the first research dressing change and will then crossover to the alternative group for the second laser procedure.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 12, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)