NCT05928910撤回不适用
Decreasing Intraprocedural Peripheral Nerve Evaluation (PNE) Pain and Anxiety Using the SmileyScope Virtual Reality
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Anxiety as Measured by State Trait Anxiety Inventory
研究概览
简要总结
The purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (PNE).
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
- •Adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction
排除标准
- •Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study
- •Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancers, etc., which could compromise the physical function of the headset
结局指标
主要结局
Change in Anxiety as Measured by State Trait Anxiety Inventory
时间窗: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
Anxiety will be measured using the State Trait Anxiety Inventory. Scores range from 0-24. Higher scores indicate greater anxiety.
Change In Pain as Measured by Numeric Pain Scale
时间窗: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
Pain will be measured using the numeric pain scale. Scores range from 0-10. Higher scores indicate worse pain.
次要结局
- Satisfaction with Procedure as measured by Likert Scale(up to one hour post-procedure)
- Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale(up to one hour post-procedure)
研究者
Raveen Syan
Assistant Professor of Clinical
University of Miami
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