NCT04437173已完成不适用
Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Anxiety Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
- •English speaking
- •Having the ability to understand oral and written instructions
- •Willing to fill out psychometric surveys.
排除标准
- •Pregnant women
- •Prisoners
- •Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
研究组 & 干预措施
Virtual Reality Arm
Experimental
Patients undergo interventional pain procedure with virtual reality distraction
干预措施: Virtual Reality Headset Distraction (Device)
No Intervention Arm
No Intervention
Patients undergo interventional pain procedure without virtual reality distraction
结局指标
主要结局
Anxiety Score
时间窗: Immediately before procedure and immediately after procedure.
State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety)
次要结局
- Patient Experience Satisfaction(Immediately after procedure)
- Pain Score(Immediately before procedure, during procedure, and immediately after procedure)
- Sedation Requirements(During course of procedure)
- Global Impression of Change(Immediately after procedure)
研究者
研究点 (1)
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