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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children
- ClinicalTrials.gov ID
- NCT06303687
- Acronym / sponsor ID
- STUDY00003496
- Conditions
- Acute Pain, Pediatric ALL, Procedural Pain, Burns
- Keywords
- Virtual Reality, VR, fNIRS, Pain, Biomarker, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR-PAT | Experimental | Other: VR-PATParticipant 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. |
| Control | No intervention | –Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-PATAlso: Virtual RealityVirtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device | Other | VR-PAT |
Primary outcome
Change in brain activity
Time frame: Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)
Mean change of hemoglobin oxygen (HBO2) concentration between VR and Control as detected by fNIRS.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henry Xiang, MD, MPH, PhD, MBA principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry Xiang, MD, MPH, PhD, MBA (614-355-5893, Henry.Xiang@NationwideChildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activity (time frame: Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.