Healthy Children and Virtual Reality Mediation of Simulated Pain

March 16, 2026 updated by: Henry Xiang, Nationwide Children's Hospital

Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Anxiety and Pain Management

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans 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 virtual reality (VR)-based pain reduction approaches for pain management in clinical trials.

20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fNIRS neuroimaging device while playing an immersive/engaging VR game, a passive VR video, and an iPad game.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans 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.

Collaboration will occur through a team science model 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 simulated pain condition.

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 6-17 years, inclusive
  • Subjects and legal guardians can communicate (read and write) using English

Exclusion Criteria:

  • Currently experiencing any pain (acute or chronic)
  • Took any pain medication within the past 12 hours
  • 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, incarcerated, or currently pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. No distraction tool will be used.
Experimental: Active VR-PAT
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants actively play an engaging virtual reality game on a VR headset.
Other: Active VR-PAT
Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset. Both engagement and immersion.
Active Comparator: Passive VR-PAT
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants view a video of the same VR game on a VR headset, without engagement.
Other: Passive VR-PAT
VR-PAT hosted on a Pico Neo 3 Pro Eye headset, with the active game participation removed. Immersion with engagement removed.
Active Comparator: iPad game
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants actively play the same VR game on an iPad, without the immersion of a VR headset.
Other: iPad
VR-PAT hosted on an Apple iPad. Engagement with immersion removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions
Time Frame: Assessed continuously throughout the simulated pain session (60 minutes) for one visit
Mean within subject fNIRS signals of brain activation
Assessed continuously throughout the simulated pain session (60 minutes) for one visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Henry Xiang, MD, MPH, PhD, MBA, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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