Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in brain activity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VR-PAT
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.
干预措施: VR-PAT (Other)
Control
Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change.
结局指标
主要结局
Change in brain activity
时间窗: 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.
次要结局
- Change in procedural 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(Within 15 minutes immediately following burn dressing change when in VR-PAT group)
- Procedural pain during burn dressing changes(Assessed within 15 minutes immediately after the burn dressing change about pain experienced during the procedure)
研究者
Henry Xiang
Professor of Medicine and Center Director
Nationwide Children's Hospital