Healthy Children and Virtual Reality Mediation of Simulated Pain

Nationwide Children's Hospital

Status: Invitation-only

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

Treatments: Other: Passive VR-PAT; Other: Active VR-PAT; Other: iPad

Study type: Interventional

Funder types: Other

Identifiers

NCT06854991

STUDY00004727

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Active VR-PAT

Passive VR-PAT

Active Comparator group

Description:

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.

Treatment:

Other: Passive VR-PAT

iPad game

Active Comparator group

Description:

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.

Treatment:

Other: iPad