Virtual Reality for Preoperative Anxiety in Interventional Cardiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography
研究概览
简要总结
Improving the management of perioperative anxiety is important. Anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. These findings are also true in interventional cardiology. That is why, for several months, the Grenoble University hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). Following a survey of the patients of Grenoble university hospital, a gray area persists in their care. The room where the patient attends his examination. The investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.
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
- •Major male or female patient
- •Coronarography procedure programmed for exploration of coronary artery disease following a positive ischemia test, realized in ambulatory
- •Patient who has given written consent to participate in the study
排除标准
- •Arrhythmia patient and / or patient with a pacemaker
- •Hemodynamic instability
- •Patient who has already had coronarography
- •Prior revascularization by coronary bypass
- •End-stage renal disease (Creatinine clearance <30 ml / min),
- •Allergy to iodine contrast agent
- •Blind or visually impaired patient (high degree)
- •Deaf or hard of hearing patient
- •Patient with claustrophobia or unable to wear a mask over the eyes
- •Patient whose physical or psychological state could compromise obtaining informed consent and compliance with protocol requirements
- •Patient under administrative or judicial supervision
- •Foreign patient who does not understand French
- •Major patient protected by law (article L1121-8 and L1121-5)
- •Pregnant or lactating patient
- •Patient not affiliated with social security
结局指标
主要结局
Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography
时间窗: Time 1 : 60 minutes
Heart rate variability during 20 minutes by a heart rate monitor in transfer room
次要结局
- Impact of virtual reality on coronarography scopy time(Time 2 : 120 minutes)
- Evaluation of anxiety level in patient awaiting coronarography(TIme 1 : 60 minutes, Time 2 : 120 minutes)
- Patient satisfaction on the global care in the coronary angiography room(Time 3 : 180 minutes)
- Impact of virtual reality on coronarography intervention duration(Time 2 : 120 minutes)
- Impact of virtual reality on coronarography irradiation dose(Time 2 : 120 minutes)
- Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedure(Time 2 : 120 minutes)
- Impact of virtual reality on rate and success of coronarography procedure(Time 2 : 120 minutes)