Acute Pain, Experimental Pain in Healthy Human Participants, Children, Adolescents
Conditions
Keywords
Acute Pain, Experimental Pain, Virtual Reality, fNIRS
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.
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.
Interventions
OTHERActive VR-PAT
Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset. Both engagement and immersion.
OTHERPassive VR-PAT
VR-PAT hosted on a Pico Neo 3 Pro Eye headset, with the active game participation removed. Immersion with engagement removed.
OTHERiPad
VR-PAT hosted on an Apple iPad. Engagement with immersion removed.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions | Assessed continuously throughout the simulated pain session (60 minutes) for one visit | Mean within subject fNIRS signals of brain activation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHenry Xiang, MD, MPH, PhD, MBA
Nationwide Children's Hospital
Outcome results
None listed