Virtual Reality Hypnosis as Sedation During Oocyte Retrieval: Effect on Propofol Consumption: a Randomized Study (VRH-IVF)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- The primary outcome of this study is to compare VRH with a control group (usual sedation) on propofol consumption during the procedure.
研究概览
简要总结
An egg retrieval is performed during an IVF course. This painful procedure is performed using sedation to ensure patient comfort. A combination of sedative and analgesic medications combined with local anesthesia (paracervical block) is used. Propofol, the intravenous anesthetic of choice (rapid-acting and short-acting), and remifentanil (an ultra-short-acting opioid analgesic) are generally combined. The potential impact of these agents used for egg retrieval on egg fertilization and embryo quality is of interest. Indeed, certain drugs such as propofol could accumulate in the follicular fluid. The few studies conducted to date show contradictory results. While a harmful effect appears to be reported in experimental studies on mice, this effect is uncertain in clinical studies. Given this uncertainty, any method aimed at reducing propofol consumption in this context may be of interest. Virtual reality hypnosis (VRH) is a digital tool that has already been shown to be effective in reducing preoperative anxiety during oocyte retrieval. Furthermore, VRH has also demonstrated analgesic effects.
The primary objective of this study is to compare VRH with a control group (usual sedation) on propofol consumption during oocyte retrieval.
Secondary objectives are to compare preoperative anxiety, APAIS score, catastrophizing score, remifentanil consumption, intra- and/or post-operative nausea and vomiting, post-procedural analgesic consumption, time perception during the procedure, fertilization parameters, and pregnancy rate at 12 weeks. The degrees of absorption, dissociation, immersion, and presence for the VRH group will also be noted.
详细描述
This is a prospective, single-center, randomized, controlled interventional study that will include 72 patients. Patients will be randomized into two groups: a Control group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) during the retrieval, and an RVH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety. To be included, patients must have undergone egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc, be French-speaking, have undergone simple IVF or ICSI IVF, and must not be undergoing long-term psychotherapeutic treatment or taking psychotropic medications. They must also have given their free, informed and written consent signed by the investigator and the patient in the days preceding the intervention. Patients with morbid obesity, blindness and/or deafness and with a history contraindicating the use of anti-inflammatory drugs will be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc,
- •to be French-speaking,
- •simple IVF or ICSI IVF
- •18-42 yrs
排除标准
- •morbid obesity
- •blindness and/or deafness
- •history contraindicating the use of anti-inflammatory drugs
- •long-term psychotherapeutic treatment or taking psychotropic medications.
研究组 & 干预措施
control group
sedation with remifentanil and propofol
RVH group
RVH session + sedation with remifentanil and propofol
干预措施: virtual reality hypnosis device (Other)
结局指标
主要结局
The primary outcome of this study is to compare VRH with a control group (usual sedation) on propofol consumption during the procedure.
时间窗: Day 0
次要结局
未报告次要终点
