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NCT06854991 | NOT YET RECRUITING | Acute Pain

Healthy Children and Virtual Reality Mediation of Simulated Pain
Sponsor:

Nationwide Children's Hospital

Information provided by (Responsible Party):

Henry X i

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.

Condition or disease

Acute Pain

Experimental Pain in Healthy Human Participants

Children

Adolescents

Intervention/treatment

Active VR-PAT

Passive VR-PAT

iPad

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Anxiety and Pain Management
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Healthy Children and Virtual Reality Mediation of Simulated Pain

Location Details

NCT06854991

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Locations

Not yet recruiting

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205