Healthy Children and Virtual Reality Mediation of Simulated Pain

Conditions

• Acute Pain
• Adolescents
• Children
• Experimental Pain in Healthy Human Participants

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Aug 4, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• 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.
• 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.
• 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.

Primary Outcome Measure

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 ]

Locations (1)

Find similar trials in Columbus, OH

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