Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in In Vitro Fecondation Protocols: Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain during oocyte retrieval, assessed by NRS
研究概览
简要总结
The aim of the study is to ass wether or not the use of virtual reality during oocyte retrieval provides a better pain relief for patients, compared to a standard analgesic procedure.
详细描述
Patients will be included during the consultation with the gynaecologist, whom will explain the protocol to the patient and give her the consent to sign.
The patient will be then randomized by a computer (using the software REDCAP) into either the experimental group or the standard group.
In the experimental group, a virtual reality device will be installed on the patient as soon as she arrives in the operating room, and the intervention will start after 3-5 minutes.
In both group, the patient will benefit of a local anesthesia in the vagina, and if they want it of an oral analgesic before the intervention.
Just at the end of the intervention, the pain will be evaluated orally by the nurse, using a Numeric Rating Scale. This consist of the Primary Outcome.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 43 years
- •First attempt of oocyte retrieval under local anesthesia in the context of a protocol for Medically Assisted Procreation
排除标准
- •Former attempt of oocyte retrieval
- •Poor oocyte stock : > 40 years AND low markers (AMH < 0.5-1.1 ng/ml OR AFC < 5-7)
- •Unsteady epilepsia
研究组 & 干预措施
Virtual Reality Group
in this group, patients will use virtual reality during the oocyte retrieval plus the standard anesthesic procedure (local anesthesia)
干预措施: Hypnotic relaxation induced by virtual reality (device) (Device)
Virtual Reality Group
in this group, patients will use virtual reality during the oocyte retrieval plus the standard anesthesic procedure (local anesthesia)
干预措施: local anesthesia (Drug)
Standard Group
in this group, patients will receive the standard anesthesic procedure during the oocyte retrieval wich is local anesthesia
干预措施: local anesthesia (Drug)
结局指标
主要结局
Pain during oocyte retrieval, assessed by NRS
时间窗: day 0 (During the intervention for oocyte retrieval)
Oral evaluation of pain during the intervention for oocyte retrieval, evaluated by a Numeric Rating Scale (NRS) : from 0 (meaning no pain at all) to 10 (meaning worse pain possible).
次要结局
- Painkillers consumption during the 48 hours following the oocyte retrieval.(Day 5)
- Patient satisfaction concerning the use of virtual reality during the oocyte retrieval(hour 1 (In the hour following the oocyte retrival))
- Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval(hour 1 (In the hour following the oocyte retrival))
- Efficacy of the use of virtual reality during oocyte retrieval(hour 1 (In the hour following the oocyte retrival))
- Pain after oocyte retrieval, assessed by NRS(hour 1 (In the hour following the oocyte retrival))