NCT06854991

Healthy Children and Virtual Reality Mediation of Simulated Pain

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Active VR-PAT	Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset. Both engagement and immersion.
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.
OTHER	iPad	VR-PAT hosted on an Apple iPad. Engagement with immersion removed.

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-03
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States