Effect of Clinical Hypnosis in Preoperative Anxiety Among Patients Undergoing an Abdominal Surgery : a Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Preoperative anxiety
研究概览
简要总结
This Multicenter randomized controlled trial evaluates clinical hypnosis efficacy for reducing perioperative anxiety and postoperative pain in abdominal surgery patients across 3 Moroccan centers (n=48-68). Intervention arm receives 15-20 min level 2 hypnosis session preoperatively; control receives standard psychological preparation. Primary outcome: VAS-anxiety post-intervention. Secondary: postoperative EVA-pain, analgesic consumption, length of stay.
Study Design Prospective, multicenter, parallel-group RCT (1:1 allocation, stratified by center/sex). Inclusion: consenting ASA I-II adults for abdominal surgery. Primary endpoint powered for 10mm EVA reduction (80% power, α=0.05). Registration supports PhD thesis at ISSS/Université Hassan 1er Settat.
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
- None
盲法说明
This study did not use any kind of masking or blinding,
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Consenting patients undergoing abdominal surgery
- •ASA I-II physical status
- •Able to understand and respond to instructions
- •No major psychological disorders
排除标准
- •Non-consenting patients
- •Prior experience with hypnosis
- •History of mental illness
- •Psychoactive substance consumption
- •Cognitive disorders
研究组 & 干预措施
Arm 2 : patients will be treated as usual with standard conditions
Patients in this group will receive standard usual care without any hypnotic intervention, only with routine psychological preparation.
Fisrt arm: patients having a session of hypnosis prior to surgery
Patients randomized to the intervention arm undergo a single 15-20 minute clinical hypnosis session preoperatively for anxiety reduction, achieving level 2 hypnotic trance (somnambulism)
干预措施: Clincal hypnosis (Other)
结局指标
主要结局
Preoperative anxiety
时间窗: 1 hour Before surgery
Perioperative Anxiety (Primary Outcome) is measured using the Visual Analog Scale for Anxiety (EVA-Anxiété, 0-100 mm). Primary Outcome Measure: preoperative anxiety level Assessment Tool: 100-mm Visual Analog Scale (VAS-Anxiety): 0 mm = No anxiety ("Je ne suis pas du tout anxieux") 100 mm = Worst possible anxiety ("Anxiété maximale imaginable") Timepoints: (post-intervention, \~10 min later). Expected hypnosis effect: ≥10 mm reduction vs. control. Protocol Specifications Patient marking: Single horizontal 100-mm line; mark position indicates intensity Scoring: Distance (mm) from "No anxiety" (0) to mark, precise to 1 mm
次要结局
- Postoperative pain(6 and 24 hours postoperatively)
- medication consumption(Perioperative)
- length of stay(Perioperative)
研究者
YOUSSEF EL-ALLAM
Principal investigator
HASSAN 1st university