Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Assessment of pain scale
研究概览
简要总结
Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
详细描述
Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to alleviate patient anxiety. However, alternative techniques, additional non-pharmacological, have proven effective in alleviating pain and anxiety perioperative. These techniques are retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a technique of choice. Regarding medical hypnosis techniques, many studies have shown that performing a hypnotic technique performed perioperative could reduce the doses of anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a number of postoperative adverse effects.
Among the various techniques of hypnosis that can be offered to patients in the perioperative, conversational hypnosis is to accompany the patient on admission to the block to realization of general anesthesia. This technique aims to suggest a pleasant environment and not anxiety.
This study evaluate the impact of this support in reducing postoperative major adverse effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Female > 18 years
- •Patient with ASA* score 1, 2, 3
- •Minor Unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary node dissection, minor breast reconstruction…)
- •Day case surgery (ambulatory surgery - living Day0-Day1)
- •General anesthesia required
- •Written informed consent
- •French medical benefit
排除标准
- •Age < 18 years
- •Patient with ASA score > 4;
- •Body mass index < 15 or 45kg/T;
- •Major Surgery indication : mastectomy, bilateral surgery, full axillary dissection, major breast reconstruction
- •Patient refusing hypnosis
- •Psychic or mental Disorders
- •Chronic pain
- •Opiate therapeutic > 3 months
- •Not ability to speak and read French language
- •Deaf and dumb patient
- •Under guardianship patient or guardianship
结局指标
主要结局
Assessment of pain scale
时间窗: through study completion, an average of 5 year
Pain intensity assessment
次要结局
- Reduction of the pain using Visual Analogic Scale(through study completion, an average of 5 year)