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NCT Number: NCT06303687

VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

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).

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Key information

Conditions

Acute Pain Burns Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Procedural Pain Signs and Symptoms Wounds and Injuries

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experience during inpatient pediatric (age 6-17 years) burn dressing changes and pain relief induced by virtual reality (VR). We plan to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to VR-based pain reduction approaches for pain management in clinical trials.

We will collaborate through a team science model to recruit n=4 pediatric burn injury subjects to address the following three specific aims:

Aim 1: To quantify the central nervous system (CNS) responses associated with self-reported pain intensity during a standard clinical procedure (burn dressing changes).

Aim 2: To assess brain response patterns to virtual reality (VR)-based interventions for pain management.

Aim 3: To assess the degree to which objective brain measures and brain responses to VR intervention modulate objective brain markers of pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

VR-PAT

Other

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

Other names: Virtual Reality

Primary outcomes

  1. Change in brain activity

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

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

Secondary outcomes

  1. Procedural pain during burn dressing changes

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

    0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain. Collected in both VR and Control group.

  2. Change in procedural anxiety

    Time frame: 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

    Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety.

  3. Self-reported VR experience

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

    0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.

Study contacts

Contact information is provided by the study sponsor or research team.

Henry Xiang, MD, MPH, PhD, MBA

CONTACT

[email protected]

614-355-5893

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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