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临床试验/NCT03957538
NCT03957538已完成不适用

The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels in Patients Undergoing CArdiac caTHeterisation: The VIRTUAL CATH Trial

University Hospital of Wales1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年7月1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
75
试验地点
1
主要终点
Difference in pre and post procedural anxiety scores between patients receiving standard care and those who experienced the immersive VR experience

研究概览

简要总结

This study is a randomised control trial which aims to assess whether the use of an immersive virtual reality angiogram experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation.

详细描述

Patients undergoing cardiac catheterisation are understandably anxious. This is due to a lack of familiarity with both the hospital environment and the planned procedure. Anxiety may negatively affect their patient experience. Appropriate patient information can help improve understanding and reduce anxiety. In particular, video-based patient information prior to cardiac catheterisation has been shown to improve patient's knowledge and reduce peri-procedural anxiety. Generic video-based patient information about the cardiac catheterisation procedure is widely available. Ideally any patient information delivered pre-cardiac catheterization would be specific to the hospital delivering care. The use of virtual reality (VR) in healthcare is novel, but expanding rapidly. The immersive nature of VR allows patients a unique opportunity to prepare for the procedure and environment within which they will be treated. To date, the use of VR to prepare patients for invasive cardiac procedures has not been studied.

The aim of this study is to assess whether the use of an immersive VR experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation. The investigators will also assess whether the VR experience improves overall patient satisfaction.

With the help of a local media company, a VR cardiac catheterisation video was produced (Figure 1 depicts a screenshot from the VR video). The video is watched with a VR headset to create a 360 immersive experience. The investigators are undertaking a single-centre randomised control trial comparing the use of an immersive VR experience 1 week prior to catheterisation with standard pre-procedural care. Pre procedural anxiety levels and procedural knowledge are assessed by questionnaire, using the validated six-item short-form of the Strait Trait Anxiety Inventory (STAI). A satisfaction questionnaire is also completed before the patient is discharged.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • All patients undergoing their first cardiac catheterisation

排除标准

  • Patients who cannot comprehend English or Welsh
  • Those who have significant visual or auditory impairment meaning they would be unable to fully appreciate the video material

结局指标

主要结局

Difference in pre and post procedural anxiety scores between patients receiving standard care and those who experienced the immersive VR experience

时间窗: 3 months

Study data collection will be via questionnaire, including the validated six-item short-form of the Strait Trait Anxiety Inventory (STAI). The STAI is a well-established and validated measure of anxiety that can be used in various clinical settings. The investigators chose the STAI as the primary outcome measure as it has been validated as a measure of anxiety in patients undergoing invasive cardiac procedures. Total score available is 32, minimum score 8. The higher the score the higher the anxiety.

次要结局

  • Difference in post procedure satisfaction scores between patients receiving standard care and those who experienced the immersive VR experience(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Holly Morgan

Cardiology Spr

University Hospital of Wales

研究点 (1)

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