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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-PAT | Other | Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain activity | Mean change of hemoglobin oxygen (HBO2) concentration between VR and Control as detected by fNIRS. | Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed within 15 minutes immediately after the burn dressing change about pain experienced during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henry Xiang, MD, MPH, PhD, MBA | Contact | 614-355-5893 | Henry.Xiang@NationwideChildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Henry Xiang, MD, MPH, PhD, MBA | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
No IPD will be shared
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000073818 | Pain, Procedural |
| D002056 | Burns |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
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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.
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| 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. | 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. | Within 15 minutes immediately following burn dressing change when in VR-PAT group |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |