An interventional study of VR-PAT in Acute Pain, Pediatric ALL and Procedural Pain, sponsored by Nationwide Children's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Diagnostic
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).
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.
Exclusion Criteria:
Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game while also wearing the fNIRS, during their clinically scheduled burn dressing change.
Other: VR-PAT
Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change.
Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device
Also known as: Virtual Reality
Change in brain activity
Mean change of hemoglobin oxygen (HBO2) concentration between VR and Control as detected by fNIRS.
Time frame: Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)
Procedural pain during burn dressing changes
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain. Collected in both VR and Control group.
Time frame: Assessed within 15 minutes immediately after the burn dressing change about pain experienced during the procedure
Change in procedural anxiety
Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of 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
0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.
Time frame: Within 15 minutes immediately following burn dressing change when in VR-PAT group
Plan to share: No — No IPD will be shared
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Nationwide Children's Hospital