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OpenTrials
Enrolling by Invitation

NCT Number: NCT06854991

Healthy Children and Virtual Reality Mediation of Simulated Pain

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.

Enrolling by Invitation

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Key information

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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Active VR-PAT

Other

Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset. Both engagement and immersion.

Passive VR-PAT

Other

VR-PAT hosted on a Pico Neo 3 Pro Eye headset, with the active game participation removed. Immersion with engagement removed.

IPAD

Other

VR-PAT hosted on an Apple iPad. Engagement with immersion removed.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Mar 17, 2026

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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