Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ICSI Oocyte Retrieval
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The Cp50 value of propofol in each group.
研究概览
简要总结
Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed, with the aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.
Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.
However, to date, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published. Our study will evaluate if using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.
详细描述
Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed. These devices aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.
Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.
However, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published to date. This study hypothesises that using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Over 18 and under 43 years of age.
- •Requiring propofol sedation for oocyte puncture.
- •Who can be contacted directly by telephone the day after the procedure.
- •Have given their consent to participate in accordance with the regulations.
- •Benfeting of a social security scheme or entitled persons (excluding AME).
排除标准
- •Active endometriosis.
- •Presence of at least one anatomically high ovary which is difficult to puncture.
- •Inability to understand the information provided.
- •Under guardianship, curatorship or legal protection.
- •Under psychiatric care.
- •Admitted to a health or social establishment for purposes other than this research.
- •Under constraint or deprived of liberty by judicial or administrative decision.
- •Impaired communication or neuropsychological disorders.
- •Ongoing corneal or conjunctival pathologies.
- •Claustrophobia.
- •Nausea in the mountains or at sea.
- •Use of an anxiolytic or sleeping pill in the 12 hours prior to randomisation.
研究组 & 干预措施
Experimental arm
Experimental group: the participants will receive standard propofol sedation procedure and the mask -RV Deepsen™
干预措施: Propofol sedation + Audiovisual distraction (Device)
Control arm
Control group: the participants will receive standard propofol sedation procedure
干预措施: Propofol sedation (Other)
结局指标
主要结局
The Cp50 value of propofol in each group.
时间窗: Day 0
The Cp50 is defined as the median of the target concentration at which 50% of participants showed movement during the oocyte puncture procedure. Any difference between the two groups will be determined using Dixon's up and down technique
The number and proportion of participants not requiring sedation
时间窗: Day 0
次要结局
- Pain on injection of propofol(Day 0)
- Participant satisfaction with the procedure(Day 0)
- Resumption of activities of daily living(Day 1)
- Recovery room discharge time(Day 0)
- Effect on procedural anxiety(Day 0)
- Tolerating audiovisual distraction(48 hours)
- Complications observed during anaesthesia(Day 0)
- The time required to walk(Day 0)
- Acceptance of audiovisual distraction by anaesthetists, gynaecologists and other healthcare professionals(Day 0)