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

NCT ID: NCT03485469

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-29
• Study Completion Date: 2026-10-31

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.

Conditions

Obesity; Bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Standard Care

Intervention Type: BEHAVIORAL

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)

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.

Group Type: OTHER

Hypnosis

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David NOCCA, PU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

CHR Saint Pierre - maladies métaboliques

La Réunion, , France

Site Status: RECRUITING

Cécile GODEL

Montpellier, , France

Site Status: RECRUITING

Orléans University Hospital

Orléans, , France

Site Status: RECRUITING

Reims University Hospital

Reims, , France

Site Status: RECRUITING

Toulouse University Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cécile GODEL, Dietetician

Role: CONTACT

c-godel@chu-montpellier.fr

04.67.33.79.52 ext. +33

Mélanie DELOZE, CRA

Role: CONTACT

m-deloze@chu-montpellier.fr

Facility Contacts

Nathalie LEMOULEC

Role: primary

Cécile GODEL, Dietetician

Role: primary

c-godel@chu-montpellier.fr

04.67.33.79.52

Mélanie DELOZE, CRA

Role: backup

m-deloze@chu-montpellier.fr

Elise MONGEOIS

Role: primary

Eric BERTIN

Role: primary

Patrick RITZ

Role: primary

Other Identifiers

UF 9793

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL17_0024

Identifier Type: -

Identifier Source: org_study_id