NCT04711278已完成不适用
Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Anxiety assessment at baseline
研究概览
简要总结
The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.
详细描述
As secondary objectives, the study aims
- to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain;
- to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient ≥ 18 years;
- •Autonomous patient living at home;
- •Affiliated to a social security scheme;
- •Informed consent signed by patient;
- •Patient will undergo a planned ambulatory surgery for hallux valgus.
排除标准
- •Inability to understand STAI-A questionnaire;
- •Patient refusal;
- •Patient underwent a bilateral surgery;
- •Patient judicial decision;
- •Covered by french AME health system.
研究组 & 干预措施
hypnosis group
Experimental
Mask-wearing as hypnosis method for patients in this arm.
干预措施: Mask-wearing hypnosis (Device)
comparator group
Sham Comparator
No hypnosis for patients in this arm.
干预措施: Without hypnosis (Other)
结局指标
主要结局
Anxiety assessment at baseline
时间窗: baseline, pre-intervention
The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
Anxiety assessment after the surgery
时间窗: immediately after the surgery
The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
次要结局
- Analgesic taken(at the end of study, an average of 1 day)
- Duration of stay(at the end of study, an average of 1 day)
- Pain assessment(day 1)
研究者
研究点 (2)
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