VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

Acute Pain Clinical Trial

Official title:

Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06303687
• Other study ID #: STUDY00003496
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Burns
• Pain, Procedural
• Pediatric ALL
• Procedural Pain

Intervention

Other:
• VR-PAT
Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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
Secondary	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
Secondary	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