Anxiety Reduction in TAVI Using Virtual Reality Trial (ART-VR)
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Zuid Holland
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Rotterdam、Zuid Holland、荷兰、3015 GD
- 招聘中
- Erasmus University Medical Center
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接触：
- Nicolas Van Mieghem
- 邮箱：n.vanmieghem@erasmusmc.nl
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Epilepsy
- Extensive cognitive impairment (MMSE <21 or as diagnosed by geriatrician)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：VR-immersion
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An immersive virtual reality experience will be generated by a head mounted device which shows the user pre-recorded videos (SynVR Relax & Distract, SyncVR Medical BV, Utrecht, The Netherlands).
These videos are recorded in 360 degree views and matched with the users' viewing direction by the head mounted device matches.
The user will not be able to see its in vivo surroundings (i.e. the Cathlab) and will be focused on the digital content.
The VR immersion will be put into place throughout the entire TAVR procedure starting before femoral access obtainment and ending after access closure.
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无干预：Non-VR control
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Procedural Anxiety
大体时间：Immediately after the TAVR procedure
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Procedural anxiety assessed on a visual analogue scale directly post-procedure.
Range: 0 (no anxiety) to 10 (worst anxiety).
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Immediately after the TAVR procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of Anxiety
大体时间：1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
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Difference between pre-procedural and post-procedural anxiety visual analogue scale scores
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1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
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Procedural Pain
大体时间：Immediately after the TAVR procedure
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Procedural pain assessed on a visual analogue scale directly post-procedure.
Range: 0 (no pain) to 10 (worst pain).
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Immediately after the TAVR procedure
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Procedural Use of Sedatives
大体时间：Up to 1 day (Depending on procedure duration)
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Procedural sedative use and dosage.
Amount of benzodiazepine used in milligrams
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Up to 1 day (Depending on procedure duration)
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Procedural Use of Analgesics
大体时间：Up to 1 day (Depending on procedure duration)
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Procedural analgesic use and dosage.
Amount of Lidocaine (or equivalent) used in milligrams
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Up to 1 day (Depending on procedure duration)
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Patient Procedural Satisfaction
大体时间：One day post procedure
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Procedural satisfaction assessed after 24hrs using for procedures under regional anaesthesia.
Score assessed on a visual analogue scale.
Range: 0 (not at all satisfied) to 10 (very satisfied).
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One day post procedure
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient reported procedural Nausea and Vomiting
大体时间：Up to 1 day (Depending on procedure duration)
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Patient reported nausea and vomiting during the procedure (yes/no)
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Up to 1 day (Depending on procedure duration)
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Admission time
大体时间：Up to 7 days
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Time leaving cathlab until discharge
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Up to 7 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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