NCT05567315已完成不适用
Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure: a Randomised Controlled Study
Clinique Mutualiste la Sagesse1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2022年10月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Analgesia Nociception Index (ANI) measurement
研究概览
简要总结
Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture
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
- Single (Outcomes Assessor)
盲法说明
The person collecting the endpoints will be blinded to the treatment group
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient having an oocyte puncture as part of a medically assisted procreation procedure
- •Surgical procedure planned in the operating theatre under local anaesthesia at the Clinique Mutualiste La Sagesse
- •Patient capable of receiving and understanding information about the study and giving written informed consent.
- •Affiliated to a social security system
排除标准
- •Patient's refusal to participate in a study
- •Patient having an oocyte retrieval as part of an oocyte donation
- •Unbalanced epilepsy.
- •Hearing and/or visual impairments that contraindicate the use of the virtual reality headset.
- •Patient with a poor understanding of the French language.
- •Medical indication to carry out the oocyte puncture under general anaesthesia
- •Drug allergy or hypersensitivity to PARACETAMOL - IBUPROFEN or NEFOPAM prescribed during the pre-medication.
- •Patient under legal protection
研究组 & 干预措施
Oocyte puncture with local anaesthesia alone
Active Comparator
干预措施: local anaesthetic injection (Drug)
Oocyte puncture with local anaesthesia and additional virtual reality hypnosis
Experimental
干预措施: local anaesthetic injection (Drug)
Oocyte puncture with local anaesthesia and additional virtual reality hypnosis
Experimental
干预措施: hypnosis with Virtual reality mask (Device)
结局指标
主要结局
Analgesia Nociception Index (ANI) measurement
时间窗: during oocyte puncture procedure
The level of pain perceived by the patient during the performance of a painful care procedure will be measured by the ANI index which reflects heart rate variability
次要结局
- Analog visual scale (AVS)(Immediately after the intervention)
- Total duration of the procedure of oocyte ponction (min)(From the first ponction of local anesthesia to the end of the retrieval of the last oocyte)
- Anxiety with beck anxiety inventory(1 hour before intervention and immediately after the intervention)
- Conversion rate from local anaesthesia to unplanned general anaesthesia(Immediately after the intervention)
- Simulator Sickness Questionnaire (SSQ)(Immediately after the intervention)
- Post intervention analgesic therapy(Immediately after the intervention)
- Gynecologist's numerical satisfaction scale(Immediately after the intervention)
- Patient's numerical satisfaction scale(Immediately after the intervention)
研究者
Vincent Denoual
Anesthesiologist
Clinique Mutualiste la Sagesse
研究点 (1)
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