Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Analgesia assessment by digital pain scale
研究概览
简要总结
The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.
Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.
The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.
The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.
The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Digestive endoscopy procedure under general anesthesia in one of the participating centers
- •Patient speaking and understanding French
- •Patient affiliated or entitled to a social security scheme
- •Patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection
排除标准
- •Patient with deafness
- •Patient with cognitive impairment
- •Pregnant and / or breastfeeding patient
- •Patient with dissociative disorders (contraindication to hypnosis)
- •Patient suffering from a pathology which can cause chronic pain
- •Patient receiving analgesia or anxiety drug
- •Patient under justice, curatorship or tutorship
- •Patient deprived of liberty by judicial or administrative decision
结局指标
主要结局
Analgesia assessment by digital pain scale
时间窗: immediately after applying the peripherical veinous catheter dressing
Digital pain scale: it describes the severity of the pain On this scale, "0" represents "no pain" and "10" represents "the worst possible pain"
次要结局
- Heart rate(during the procedure)
- Nurse anesthetist feeling about using the script after each use by digital scale(immediately after procedure)
- Level of anxiety by numerical scale(before randomization and immediately after peripherical veinous catheter set up)
- patient satisfaction within the perioperative period (EVAN G questionnaire)(between 4 and 48 hours after the procedure)