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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Change in weight in 5 months
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in weight in 5 months
Time Frame: 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.
Secondary Outcomes
- 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)