Anxiety Reduction in TAVI Using Virtual Reality Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Procedural Anxiety
研究概览
简要总结
The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (TAVR) under local anaesthesia.
详细描述
Virtual reality (VR) allows patients to be fully immerged in an engaging, interactive 3D environment. Its applications are broad and include treatment of phobias, stress-disorders, pain reduction. Recently, VR has been adopted in various medical procedures to reduce pre- and per-procedural anxiety. In TAVR, per-procedural VR immersion could potentially reduce patient anxiety leading to increased overall patient satisfaction. However, contemporary large scale, randomized evidence on VR application in TAVR is lacking.
The objective of this trial is to evaluate the effect of an immersive VR environment on procedural anxiety in patients undergoing TAVR under local anaesthesia in a randomized controlled setting. A total of 150 patients with severe aortic stenosis (AS) who undergo transfemoral TAVR under local aneasthesia will be included. The main study endpoint is procedural anxiety assessed on a visual analogue scale (VAS) directly post-procedure.
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
- •Age ≥ 18 years
- •Symptomatic severe aortic stenosis
- •Indication for transfemoral TAVI under local anaesthesia per local heart team consensus
- •Patient is able to understand and sign written informed consent
- •Patient speaks Dutch, German or English
排除标准
- •Need for emergent TAVI
- •Need for planned concomitant cardiac intervention during index procedure
- •History of TAVI under local anesthesia/conscious sedation
- •Chronic use of benzodiapines, opioids, pregabalin or antidepressants
- •History of opioid use (within 8-30 days prior to randomization)
- •Claustrophobia
- •Any psychiatric illness diagnosed by a psychiatrist or psychologist
- •Blindness or severe visual impairment despite visual aid (glasses, contact lenses)
- •Extensive cognitive impairment (MMSE <21 or as diagnosed by geriatrician)
结局指标
主要结局
Procedural Anxiety
时间窗: Immediately after the TAVR procedure
Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety).
次要结局
- Change of Anxiety(1 day (From directly before the TAVR procedure until directly after the TAVR procedure))
- Procedural Pain(Immediately after the TAVR procedure)
- Procedural Use of Sedatives(Up to 1 day (Depending on procedure duration))
- Procedural Use of Analgesics(Up to 1 day (Depending on procedure duration))
- Patient Procedural Satisfaction(One day post procedure)
研究者
Nicolas van Mieghem
Prof. Dr. Nicolas Van Mieghem
Erasmus Medical Center