NCT03485469

The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Bariatric Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Hypnosis	There ar 10 hypnosis sessions : * 1st session of hypnosis : relaxation and orientation towards "emotional cleansing". * 2nd session of hypnosis: oriented towards digestion, physical and psychological * 3rd session of hypnosis: oriented towards the feeling of security. * 4th session of hypnosis: self-esteem oriented. * 5th hypnosis session: oriented towards emotional management. * 6th hypnosis session: oriented towards self-confidence. * 7th hypnosis session: oriented towards the completion of the projects. * 8th, 9th and 10th sessions: concern the learning of self-hypnosis and autonomy. A USB key containing the induction of a session of autohypnosis will be given to the subject to promote the continuation of home-made auto-hypnosis.
BEHAVIORAL	Standard Care	The dietary advice given during these dietary consultations is part of the standard care adapted to patients who have undergone bariatric surgery while increasing the frequency of consultations (Fractionation of meals, Volume of meals, Taking meals, Drinks, Food diversity)

Timeline

• Start date: 2019-03-29
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2018-04-02
• Last updated: 2025-01-17

Locations

5 sites across 1 country: France