VR-PAT and fNIRS to Identify CNS Biomarkers of Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-PAT.
- Who it may be relevant to
- Registry conditions: Acute Pain, Pediatric ALL, Procedural Pain, Burns. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children
Overview
This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).
Detailed description
The objective of this study is to develop central nervous system (CNS) biomarkers of pain experience during inpatient pediatric (age 6-17 years) burn dressing changes and pain relief induced by virtual reality (VR). We plan 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.
We will collaborate through a team science model to recruit n=4 pediatric burn injury subjects 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 standard clinical procedure (burn dressing changes).
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
- Other VR-PAT
Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device
Primary outcome measures
- Change in brain activity [Time frame: Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)]
Secondary outcome measures (3)
- Procedural pain during burn dressing changes [Time frame: Assessed within 15 minutes immediately after the burn dressing change about pain experienced during the procedure]
- Change in procedural anxiety [Time frame: Assessed at 3 time points (30 minutes prior to procedure, immediately prior to procedure, and within 15 minutes immediately following the procedure) for each dressing change]
- Self-reported VR experience [Time frame: Within 15 minutes immediately following burn dressing change when in VR-PAT group]
Eligibility criteria
Inclusion criteria
- Being treated for acute burn injury
- Age 6-17 years, inclusive
- Admitted to NCH burn unit for treatment
- Have a dressing that requires daily changes over 3 days
- Patient and family caregivers can communicate (read and write) using English
Exclusion criteria
- Any wounds that may interfere with study procedures
- 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, prisoners, or currently pregnant
- Suspected child abuse
- Unable to communicate in English
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT06303687 · STUDY00003496