NCT05590078已完成不适用
Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change of Anxiety
研究概览
简要总结
This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.
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
- •ASA I-II (classification of the American Society of Anesthesiologists).
- •Ambulatory surgery scheduled
- •Score STAI YA > 45
- •Affiliated to a social security
- •Understanding the study and signing the informed consent
排除标准
- •Contraindications for Midazolam
- •Patients with disorders not compatible with virtual reality: severe cognitive or psychiatric disorders, blindness, claustrophobia, epilepsy
- •Patient with a pacemaker of others implantable medical devices
- •patient with burns or wounds on the upper face or scalp
- •Visual hallucinations
- •Contagious disease by air or indirect contact
- •Person unable to express their consent
- •Minor patient or patient under curatorship or guardianship
- •patient participating in another interventional clinical trial
结局指标
主要结局
Change of Anxiety
时间窗: D0 : baseline and right before going to surgery
Measured by State-Trait Anxiety Inventory (STAI YA) . The scale includes twenty items.. Each question is assigned 1 to 4 points, giving a score of 20 (low anxiety) to 80 points (high anxiety)
次要结局
- Number of milligrams of midazolam administered(D0 (before surgery))
- Pain score(D0 (after surgery))
- Virtual Reality Satisfaction Score(through study completion, 1 day)
- Adverse events related to the virtual reality session(through study completion, 1 day)
- Percentage of patients with intraoperative remifentanil required(D0 (during surgery))
- Perioperative care satisfaction score(through study completion, 1 day)
- Experience of the caregiver(D0 (before surgery))
- Morphine dose used(D0 (after surgery in recovery room))
- Nature and severity of adverse events(through study completion, 1 day)
研究者
研究点 (1)
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