The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery (NCT03485469) | Clinical Trial Compass
CompletedNot Applicable
The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery
France60 participantsStarted 2019-03-29
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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
Exclusion criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.