A Prospective Randomized Clinical Trial, in Open-label, Multicenter, Estimating the Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change in weight in 5 months
研究概览
简要总结
The therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.
详细描述
he therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.
There are still no studies assessing the impact of hypnotherapeutic management and self-hypnosis on the weight curve, self-esteem, stress, anxiety, or the quality of life of patients Obese in failure of bariatric surgery.
It is an Interventional, prospective, multi-center, controlled, randomized, open-label study with 2 parallel arms, evaluating the efficacy of hypnotherapeutic management in patients with bariatric surgery failure, compared to dietary monitoring alone.
Number of visits: 13 visits are planned: 1 visit of inclusion, a visit ensuring the first dietary follow-up, 9 hypnosis sessions (for the experimental group), two visits dedicated to the collection of the judgment criteria. Each patient is followed for 12 months.
The estimated duration of recruitment is 18 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese patient (BMI = 30 kg / m ²)
- •18 - 65 years ( inclusive borders)
- •Patient in failure of bariatric surgery and in which no surgical resumption can be proposed (in view of Reinhold's classification, the failure will be considered as a loss of overweight lower than 50 % in two years further to a bariatric surgery).
- •Informed consent
- •Patient in measure to realize all the visits and to follow the procedures of the study - Subject affiliated to a social security system
排除标准
- •Pregnancy current or planned during the duration of the study, pregnant or breast-feeding women
- •Craniopharyngioma or any other evolutionary malignant pathology, or chronic illness in decompensation phase
- •Strong probability of not compliance to the protocol or drop-out
- •Psychiatric pathology of dissociated type (schizophrenia; psychosis, bipolarity …)
- •Sensory (hearing, visual) or cognitive deficits susceptible to hinder the progress of the sessions.
- •Incapacity to understand the nature and the purpose of the study and\or communication difficulties with the investigator
- •Patient having already benefited from a coverage by hypnotherapy for loss of weight
- •Taken by treatment having an impact on the loss of weight (corticoid, antithyroid …)
- •Major protected by the law or considered vulnerable (under guardianship)
研究组 & 干预措施
Usual Care
The control group will benefit from a standard care dietary consultation in the service and 9 dietary consultations by phone every 15 days.
干预措施: Standard Care (Behavioral)
Hypnosis
The experimental group will benefit from a dietary consultation in the service, 9 dietary consultations by telephone every 15 days to which will be associated 7 individual sessions of hypnosis and 3 individual sessions of learning to autohypnosis. A recording containing the induction of a self-hypnosis session will be given to the subject at the end of the 10 sessions, in order to promote the continuation of home-made autohypnosis.
干预措施: Hypnosis (Behavioral)
结局指标
主要结局
Change in weight in 5 months
时间窗: 5 months
Patient weight (in kg) measurement will be performed on the same scale by staff who are unaware of the patient's randomization group.
次要结局
- Feeding behavior(12 months)
- Change in weight in 12 months(12 months)
- Evolution of Quality of life(12 months)
- Self-esteem(12 months)
- Anxiety and depressive state(12 months)
- Patients' satisfaction with their care(12 months)