Acute PainNCT06303687
VR-PAT and fNIRS to Identify CNS Biomarkers of Pain
A study testing VR-PAT in people with Acute Pain and Pediatric ALL, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Acute Pain, Pediatric ALL, Procedural Pain
- What is being tested?
- VR-PAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children
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).
Read the 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.
- Conditions
- Acute Pain, Pediatric ALL, Procedural Pain, Burns
- Being tested
- VR-PAT
- Keywords
- Virtual Reality, VR, fNIRS, Pain, Biomarker, Neuroimaging
- Medical subject headings
- Acute Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pain, Procedural, Burns, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-PATOther
Also called Virtual Reality
Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device
| Study group | Role | What they receive |
|---|---|---|
| VR-PAT | Experimental | 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. Receives: Other: VR-PAT |
| Control | No intervention | Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain activity
Mean change of hemoglobin oxygen (HBO2) concentration between VR and Control as detected by fNIRS.
Measured: Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Within 15 minutes immediately following burn dressing change when in VR-PAT group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startJul 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to either the intervention (fNIRS and VR-PAT) or the control (fNIRS and standard of care) at the first research dressing change and will then crossover to the alternative group for the second laser procedure.
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Xiang, Nationwide Children's Hospital
- Investigators
- Henry Xiang, MD, MPH, PhD, MBA, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303687
- Sponsor's protocol ID
- STUDY00003496
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared