Healthy Children and Virtual Reality Mediation of Simulated Pain
NCT ID: NCT06854991
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
20 participants
INTERVENTIONAL
2025-08-04
2026-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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.
No interventions assigned to this group
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.
Active VR-PAT
Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset. Both engagement and immersion.
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.
Passive VR-PAT
VR-PAT hosted on a Pico Neo 3 Pro Eye headset, with the active game participation removed. Immersion with engagement removed.
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.
iPad
VR-PAT hosted on an Apple iPad. Engagement with immersion removed.
Interventions
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Active VR-PAT
Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset. Both engagement and immersion.
Passive VR-PAT
VR-PAT hosted on a Pico Neo 3 Pro Eye headset, with the active game participation removed. Immersion with engagement removed.
iPad
VR-PAT hosted on an Apple iPad. Engagement with immersion removed.
Eligibility Criteria
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Inclusion Criteria
* Subjects and legal guardians can communicate (read and write) using English
Exclusion Criteria
* 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
6 Years
17 Years
ALL
Yes
Sponsors
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Nationwide Children's Hospital
OTHER
Responsible Party
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Henry Xiang
Director, Center for Pediatric Trauma Research
Principal Investigators
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Henry Xiang, MD, MPH, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Other Identifiers
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STUDY00004727
Identifier Type: -
Identifier Source: org_study_id
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