NCT03327506Unknown4 期
Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2018年11月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety score evaluated by STAI-Y
研究概览
简要总结
The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient's age: over 18 years
- •Patient care and follow-up at the regional maternity center of Nancy (CHRU of Nancy)
- •Female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx)
- •Patient with Physical status score (ASA) score between 1 and 3
- •With standardized anesthesia protocol
- •Patient affiliated to a Social Security
- •Patient has received complete information about the organization of the research and has signed her informed consent
排除标准
- •Pretreatment by benzodiazepines
- •Known hypersensitivity to Alprazolam® (including undocumented)
- •Prohibition conditions to Alprazolam®: Severe respiratory insufficiency, Sleep apnea syndrome, Myasthenia, Severe acute or chronic hepatic impairment
- •Ongoing major depressive episode
- •Chronic use (> 1 month) of benzodiazepines or morphine or analgesics of level 2
- •Participation in a therapeutic trial 6 months before inclusion in this trial
- •Patient referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code
研究组 & 干预措施
hypnosis group
Experimental
Intervention: hypnosis session the eve of the surgery
干预措施: Alprazolam 0.5 mg (Drug)
premedication
Active Comparator
alprazolam 0,5 mg the eve and the morning of the surgery
干预措施: Alprazolam 0.5 mg (Drug)
结局指标
主要结局
Preoperative Anxiety score evaluated by STAI-Y
时间窗: before surgery (day 2_before)
evaluated by STAI-Y self-administered questionary
次要结局
- sleep quality evaluated by EVA scale(day 2_before and the day 3)
- postoperative fatigue evaluated by EVA scale(day 3)
- Anxiety score evaluated by analogue visual scale(at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3))
- patient satisfaction score evaluated by EVA scale(day 3)
- Score of pain measured by EVA scale(day 2_after, day 2_recovery room (at the end of recovery room) and Day 3)
- analysis of salivary amylase(day 1 and day2_before)
- Intraoperative morphine and hypnotics drugs Consumption(day 3)
- Incidence of nausea and vomiting(day 3)
研究者
研究点 (1)
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