Healthy Children and Virtual Reality Mediation of Simulated Pain

NCT06854991 | Enrolling By Invitation

• 1 other identifier: STUDY00004727
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Acute Pain; Experimental Pain; Virtual Reality; fNIRS

Outcome Measures

Primary Outcomes (1)

• Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions

  Mean within subject fNIRS signals of brain activation

  Assessed continuously throughout the simulated pain session (60 minutes) for one visit

Study Arms (4)

Control

NO INTERVENTION

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.

Active VR-PAT

EXPERIMENTAL

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

Passive VR-PAT

ACTIVE COMPARATOR

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

iPad game

ACTIVE COMPARATOR

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

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.

Active VR-PAT

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.

Passive VR-PAT

iPad OTHER

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

iPad game

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henry Xiang, MD, MPH, PhD, MBA

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Pediatric Trauma Research

Model Details: All participants will start with a control condition (no distraction tool) and will then receive an Active VR, Passive VR, and iPad game distraction in random order during their experimental pain/fNIRS session.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)