Clinical trial · Interventional
VR-PAT and fNIRS to Identify CNS Biomarkers of Pain
Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children
NCT06303687CI-TRIAL-00097860not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Burns | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Procedural Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VR-PAT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VR-PAT
- description
- 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.
- interventionNames
- Other: VR-PAT
- type
- NO_INTERVENTION
- label
- Control
- description
- Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change.
Primary outcomes (1)
- measure
- Change in brain activity
- timeFrame
- Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: 1. Being treated for acute burn injury 2. Age 6-17 years, inclusive 3. Admitted to NCH burn unit for treatment 4. Have a dressing that requires daily changes over 3 days 5. Patient and family caregivers can communicate (read and write) using English Exclusion Criteria: 1. Any wounds that may interfere with study procedures 2. Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures 3. History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras 4. Minors in foster care, prisoners, or currently pregnant 5. Suspected child abuse 6. Unable to communicate in English
References
Publications (0)
Data not yet available
No reference posted for this study.