Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation (Virtual Reality) in the Breast Oncologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 4
- 主要终点
- Number of the days spent at the hospital post-surgery between the three groups
研究概览
简要总结
The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery.
Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up.
Comparisons are also performed in substudies defined by treatments modalités. Inflammatory parameters s ( CRP_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.
详细描述
Hypnosis has already demonstrated benefits among breast cancer patients undergoing oncologic surgery. Different side effects were measured during the post operative period and at each follow up visit by physicians in order to carefully compare side effects in the 3 armes of patients..
Our hypothesis was that hypnosis sedation generates less perioperative inflammatory reaction.
A substudy of 50 patients was also dedicated to the investigation ofsalivary immunoglobulins and dosage of differents endocannabinoids
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Signed informed consent form
- •Patient has to be in possession of her administrative laws and affiliated to the social security insurance.
- •The patient must have a diagnosis of resectable breast cancer (in situ or invasive breast cancer). . Surgical procedure must include evaluation of the axillary area (sentinel lymph node biopsy and or axillary dissection)
排除标准
- •Patient under 18 years old
- •No signed informed consent form
- •Patients who haven't her social security insurance and prisoners are not eligible.
- •No evaluation of the axillary area.
- •Breast cancer in men
结局指标
主要结局
Number of the days spent at the hospital post-surgery between the three groups
时间窗: Day 0, 1, 8 and every 3 months for 2 years after surgery
The aim of the study is to compare the recovering period hospitalisation and the different side effects (pain, anxiety, fatigue and consumption of pain killers ) during the post opérative period ( day 0, 1, 8- and at each follow up visit) between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery
Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio)
时间窗: Day 0, 1, 8
Blood test performed
次要结局
- Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation(Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8)