Interest of Acupressing in the Treatment of Preoperative Anxiety and Comfort of Patients Undergoing Oocyte Retrieval in Outpatient Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 45 minutes after treatment.
研究概览
简要总结
The objective of this preliminary study is therefore to assess the feasibility, safety and reduction of perioperative anxiety thanks to acupressing. In addition, patients undergoing oocyte retrieval often present postoperatively with nausea, abdominal pain and discomfort. Acupuncture could also help these patients.
详细描述
Infertility can lead to the realization of follicular puncture or oocytes in order to obtain an embryo for medically assisted procreation. It is a long treatment for the couples concerned and this intervention, relatively simple in young patients, is associated with a very high level of anxiety. According to studies, the incidence of preoperative anxiety ranges from 11% to 80% in adult patients. In patients undergoing outpatient surgery, anxiolytics are not administered before anesthesia in outpatient surgery, as this would risk altering their "fitness for the street" and preventing their return home. Studies have shown a benefit of acupressing in the treatment of preoperative anxiety. This technique could therefore be an alternative to drug anxiety before surgery. Acupressing could also help these patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Scheduled to undergo an oocyte retrieval in outpatient surgery
- •Anxiety score ≥ 3 when they arrived in the outpatient unit
- •Subject is willing and able to provide informed consent
- •Covered by a national healthcare insurance
- •Non-Inclusion Criteria:
- •Ear's pavilion infection
- •Wrist infection
- •Previous treatment with auriculotherapy or acupuncture
- •With a planned intervention that does not allow the delay of 45 min delay (+/- 15 min) between the acupuncture treatment and the STAI assessment
- •Being deprived of liberty or under guardianship
- •Exclusion criteria
- •Patient having recourse to any treatment or method of anxiolysis the morning of the procedure, after having given her consent
- •Patient wishing to withdraw from the study
排除标准
- 未提供
结局指标
主要结局
Anxiety assessement using State-Trait Anxiety Inventory questionnaire between baseline and 45 minutes after treatment.
时间窗: Baseline to 45 minutes after treatment
Anxiety assessed by the State-Trait Anxiety Inventory questionnaire. It consists of an auto-administered test of 20 items evaluating each item from 0 to 3 on the Likert scale (0= almost never, 1 = sometimes, 2 = often, 3 = almost always). The primary endpoint is the absolute difference in the state anxiety score measured between the baseline measurement and the measurement 45 minutes after treatment.
次要结局
- Absolute difference measurement between inclusion and when leaving the recovery room(before procedure to time when leaving the recovery room (up to 2 hours))
- Absolute difference measurement between the baseline and the immediate preoperative measurement(between baseline to the immediate preoperative measurement)
- Absolute difference measurement between baseline and day 1(up 24 hours after treatment)
- Pain score measured by numeric scale when leaving the recovery room(When leaving the recovery room (up to 2 hours))
- Postoperative nausea and vomiting occurring(In the recovery room (up to 2 hours))
- Postoperative retention of urine(In the recovery room (up to 2 hours))
- Satisfaction questionnaire(In the recovery room (up to 2 hours))
- Quality of sleep measurement(up 24 hours after treatment)
- Tolerance of acupressing treatment(In the recovery room (up to 2 hours))