Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in anxiety
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Interventional transfemoral TAVI
- •Informed consent
- •Normal or corrected vision (through glasses)
排除标准
- •Patients whose communication is limited due to a language barrier
- •Patients who could not watch the 3D video due to uncorrectable vision
- •all patients with transapical TAVI were also excluded.
结局指标
主要结局
Change in anxiety
时间窗: after 24 hours
A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)
次要结局
- Time of VR(at Baseline)
- Evaluation of clinical frailty scale(at Baseline)
- Measurement of pain: visual analog scale(after 24 hours)
- Length of stay at hospital(up to 5 days)
- Occurence of vomitting(at Baseline, periprocedural and after 24 hours)
- Occurence of nausea(at Baseline, periprocedural and after 24 hours)
- Rate of Intra-hospital mortality(up to 5 days)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Principle Investigator
Heinrich-Heine University, Duesseldorf