Virtual Reality for Pain Management in Burn Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in narcotic dose
研究概览
简要总结
This study is a randomized proof-of-concept study to assess the efficacy of Virtual Reality (VR) vs standard of care in 50 adult patients in the New York Presbyterian Burn Unit. The participants who are randomized to receive the virtual reality intervention will also receive opioids, which is the standard of care and is known to be effective. Participants will be randomly assigned to two groups. The first group will receive VR during their painful procedure (e.g., wound dressing changes, physical therapy etc.) in addition to the standard of care. The other group will receive standard of care (and no VR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 years and older
- •Patients with a burn injury and is in the Burn Unit at New York Presbyterian
- •Awake, alert, ambulatory
- •The burn comprises less than 15% total body surface area (TBSA)
- •The patient does not require conscious sedation such as ketamine for staple removal or wound dressing changes
- •The patient is able to give informed consent
排除标准
- •Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
- •Current opioid abuse
研究组 & 干预措施
Treatment as Usual
Standard of care during painful event (such as wound dressing changes or physical therapy sessions).
Virtual Reality
Virtual reality-enhanced distraction using a portable head mounted display during panful events (such as wound dressing changes or physical therapy sessions) in addition to standard of care.
干预措施: Virtual Reality (Other)
结局指标
主要结局
Change in narcotic dose
时间窗: Peri-procedural: 30 minutes before to two hours after the painful event.
Dose of narcotics needed peri-procedure
Change in Pain
时间窗: Peri-procedural: 30 minutes before to two hours after the painful event.
Initial determination of the clinical efficacy of VR in reducing the total pain (determined by the subjective standard 0-10 pain scale) where 0 = no pain and 10 = worst pain.
次要结局
- Change in Anxiety Symptoms(Peri-procedural: 30 minutes before to two hours after the painful event.)
- Change in narcotic dose(Day 1 of hospitalization to last day of hospitalization (approximately 15 days))
- Change in Depressive Symptoms(Peri-procedural: 30 minutes before to two hours after the painful event.)
- Change in anxiolytics dose(Day 1 of hospitalization to last day of hospitalization (approximately 15 days))