The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery (BARIATHYPNOSE)
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|ClinicalTrials.gov Identifier: NCT03485469|
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : January 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obesity Bariatric Surgery||Behavioral: Hypnosis Behavioral: Standard Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 29, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
The control group will benefit from a standard care dietary consultation in the service and 9 dietary consultations by phone every 15 days.
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)
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.
There ar 10 hypnosis sessions :
- 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.
- Change in weight in 12 months [ Time Frame: 12 months ]Patient weight (in kg) measurement will be performed on the same scale by staff who are unaware of the patient's randomization group.
- Self-esteem [ Time Frame: 12 months ]It will be evaluated by the scale of "Rosenberg's Self Esteem Scale" (1965) validated in French. It represents an assessment of the overall self-esteem that the person can have of herself. The scale includes 10 statements measured on a scale of 1 to 4.
- Evolution of Quality of life [ Time Frame: 12 months ]it will be evaluated by the variation of the scores obtained in the self-questionnaire EQVOD (Echelle de Qualité de Vie, Obésité et Diététique) of O. Ziegler et al (2005). It's a specific quality of life questionnaire for obese people.
- Anxiety and depressive state [ Time Frame: 12 months ]It will be evaluated by the Hospital Anxiety and Depression Scale - HAD (Sigmond et al, 1983). It is a self-administered 14-item questionnaire that assesses the current level of depressive and anxious symptomatology by eliminating somatic depressions that may skew assessments.
- Feeding behavior [ Time Frame: 12 months ]
It will be evaluated by the TFEQ-R21 (Three-Factor Eating Questionnaire) self-questionnaire (Cappelleri et al, 2009).
TFEQ has been validated in the general population and has been used in many studies. It explores three components of eating behavior: cognitive restriction, uncontrolled eating, and emotional eating.
- Patients' satisfaction with their care [ Time Frame: 12 months ]It will be evaluated the Likert scales of the self-satisfaction questionnaire. It is composed of 5 Likert scales coded from 1 to 5 which will be analyzed separately
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485469
|Contact: Cécile GODEL, Dietetician||04.67.33.79.52 ext +firstname.lastname@example.org|
|Contact: Mélanie DELOZE, CRAemail@example.com|
|CHR Saint Pierre - maladies métaboliques||Recruiting|
|La Réunion, France|
|Contact: Nathalie LEMOULEC|
|Contact: Cécile GODEL, Dietetician 04.67.33.79.52 firstname.lastname@example.org|
|Contact: Mélanie DELOZE, CRA email@example.com|
|Orléans University Hospital||Recruiting|
|Contact: Elise MONGEOIS|
|Reims University Hospital||Recruiting|
|Contact: Eric BERTIN|
|Toulouse University Hospital||Recruiting|
|Contact: Patrick RITZ|
|Principal Investigator:||David NOCCA, PU-PH||University Hospital, Montpellier|