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临床试验/NCT05615675
NCT05615675已完成不适用

Immersive Audiovisual Distraction With Virtual Reality (VR) in Prone Procedures in the Interventional Pain Clinic

University of California, Davis2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Anxiety Score

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.

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

入选标准

  • Patients aged 18 years old or older, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
  • English speaking and with the ability to understand oral and written instructions

排除标准

  • Pregnant women
  • Prisoners
  • Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment

结局指标

主要结局

Anxiety Score

时间窗: 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

  • Global Impression of Change(Immediately after procedure)
  • Pain Score(Immediately before procedure, during procedure, and immediately after procedure)
  • Anxiety Score(Immediately before procedure, during procedure, and immediately after procedure)
  • Patient Experience Satisfaction(Immediately after procedure)
  • Sedation Requirements(During course of procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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