Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Anxiety level
研究概览
简要总结
The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.
The main question it aims to answer:
- Is there a significant decrease on anxiety level thanks to VR-assistance?
Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.
Researchers will compare standardised anxiety scores with a control group.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Indication for prostate biopsies
- •Informed consent
排除标准
- •Local anaesthesia contra-indication (allergy)
- •Claustrophobia
- •Major cognitive impairment and impossibility of answering the standardised questionnaires
研究组 & 干预措施
Virtual Reality assistance group
Patient receiving VR headset during prostate biopsies
干预措施: Use of Virtual Reality Assistance during prostate biopsies (Device)
Control group
结局指标
主要结局
Anxiety level
时间窗: On the day of the biopsies (before the procedure) and one day after procedure
State-Trait Anxiety Inventory (STAI) validated questionnaires
次要结局
- Biopsies complications(In the 30 days following prostate biopsies)
- Anxiety level of the surgeon(One day after procedure)
研究者
Sylvain Vanoli
Principal investigator
University Hospital, Geneva