Behavioural Intervention

Virtual Reality for Acute Pain in Children

Columbus, OH

N/A

Waitlist Available

Led By Henry Xiang, MD, MPH, PhD, MBA

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 6-17 years, inclusive

Be younger than 18 years old

Must not have

Took any pain medication within the past 12 hours

History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed continuously throughout the simulated pain session (60 minutes) for one visit

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to identify biomarkers in the brain related to pain experienced during medical procedures and how Virtual Reality Pain Alleviation Therapy (VR-PAT) can help relieve pain. The researchers will use

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Who is the study for?

This trial is for healthy children who can participate in a study involving simulated pain and virtual reality. They will be part of an experiment to understand how the brain reacts to pain and if VR can help manage it.Check my eligibility

What is being tested?

The study tests how different forms of distraction (an immersive VR game, a passive VR video, and playing on an iPad) affect the brain's response to simulated pain using fNIRS neuroimaging technology.See study design

What are the potential side effects?

Since this trial involves non-invasive methods like VR games and videos with no medication or invasive procedures, side effects are minimal but may include discomfort from wearing the blood pressure cuff or temporary dizziness from VR.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 17 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken pain medication in the last 12 hours.

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I have a history of motion sickness, seizures, dizziness, or migraines triggered by visual auras.

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I am currently experiencing pain.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed continuously throughout the simulated pain session (60 minutes) for one visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed continuously throughout the simulated pain session (60 minutes) for one visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed continuously throughout the simulated pain session (60 minutes) for one visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Active VR-PATExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 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.

Group III: Passive VR-PATActive Control1 Intervention

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.

Group IV: iPad gameActive Control1 Intervention

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.

0 / 4Eligibility criteria met