Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable
研究概览
简要总结
Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.
HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.
This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.
Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.
详细描述
Consent female patients between 18 and 43 years old scheduled for oocyte retrieval will be enrolled in this study and their anxiety level will be collected via a questionnaire.
After randomization, patients will either benefit from audiovisual distraction using HappyMed Video Glasses, (medical device with CE marking), or from the usual management during procedure. The anaesthesiologist will check that no anxiolytic or sedative drug was given 12 hours before anaesthesia. The patients will be stratified according to whether or not a previous intervention was performed. Anaesthesia will be started and maintained with administration of sufentanil (0.1 μg/kg) and propofol (using the Dixon's up-and-down method). The aim is a patient who spontaneously ventilates and does not react to gynaecological stimulation. Prevention of postoperative pain and nausea/vomiting will be carried out at the initiation of the surgical procedure. The effect of these drugs is longer than the intervention duration and will not influence the protocol.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing oocyte retrieval requiring a sedation associating sufentanil and propofol
- •Contactable by phone the day after the procedure.
- •Consent for participation
- •Affiliation to the social security system
排除标准
- •Corneal or conjunctival diseases in progress,
- •Claustrophobia
- •Patients under protection of the adults (guardianship, curators or safeguard of justice)
- •Communication difficulties or neuropsychiatric disorder
研究组 & 干预措施
Audiovisual distraction
Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.
干预措施: HappyMed Video Glasses (Device)
Usual care
Sedation according to Dixon's up-and-down method.
干预措施: Propofol (Drug)
Usual care
Sedation according to Dixon's up-and-down method.
干预措施: Sufentanil (Drug)
Audiovisual distraction
Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.
干预措施: Propofol (Drug)
Audiovisual distraction
Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable
时间窗: Intraoperative period : from the start of anaesthesia to the end of the intervention
An up and down method will define the CP 50 in each group.
次要结局
- Resumption of walking(12 hours)
- Health staff satisfaction(2 hours)
- Patient satisfaction(4 hours)
- Complications due to anaesthesia(up to 24 hours (from the start of anaesthesia to the patient's discharge of the recovery room))
- Side effects due to audiovisual distraction(4 hours)
- Patient comfort during propofol injection(30 minutes)
- Resuming activities of daily living(24 hours)