Decreasing Intraprocedural Peripheral Nerve Evaluation (PNE) Pain and Anxiety Using the SmileyScope Virtual Reality
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
研究组 & 干预措施
SmileyScope VR Group
Participants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes.
干预措施: SmileyScope VR (Device)
No VR Group
Participants in this group will receive standard of care treatment.
干预措施: Standard of Care Treatment (Other)
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