Impact of the Use of VERT on Body Image After Bariatric Surgery (BARIAREV)

Impact of the Use of Virtual Reality Exposure Therapy on Body Image After Bariatric Surgery

The purpose ot the study is to assess the effectiveness of the use of VERT on improving body image at 12 months in patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after bariatric) presenting dissatisfaction with their body image compared to standard follow-up in post-bariatric surgery (lack of specific management of body image).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Device: Experimental; Other: Control

Detailed Description

Virtual reality therapy makes it possible to work on the integration of proprioceptive information via the reproduction of environments close to reality and therefore allow the patient to accept his new identity. This tool is used in an increasing number of indications and in particular in the management of dysmorphophobia in patients suffering from anorexia nervosa. In the context of bariatric surgery, only case reports have been published so far. Significant improvements in the body satisfaction scores of patients have been showed, in patients who had undergone bariatric surgery who presented bodily dissatisfaction after 6 weeks of virtual reality. However, larger numbers, longer follow-up periods and more rigorous methodologies are needed to confirm the impact of this practice. The hypothesis of the study is that virtual reality therapy could improve body image in patients who are dissatisfied with their body image after bariatric surgery.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Libourne, France, 33500
    • CH de Libourne - Hôpital Robert BOULIN
  • Pessac, France, 33604
    • Chu de Bordeaux - Hopital Haut-Leveque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• inclusion criteria: patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after surgery) presenting dissatisfaction with their body image according to the BSQ (score ≥ 111), to be affiliated to the French social security system. The prior, free and informed consent of the patient shall be obtained.
• exclusion criteria: patients with disabling nausea (Motion Sickness) from previous use of a virtual reality headset, patients who had from post-bariatric reconstructive surgery, epileptic patients, decompensation of a psychiatric pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expérimental; Virtual Reality Exposure Therapy will be realised.	Device: Experimental; Virtual reality sessions with a psychologist (30 minutes per session) once a week for 10 weeks. Work of the psychologist on a virtual environment created for the protocol in partnership with the company.
Active Comparator: Control; Standard care without VRET	Other: Control; Standard care is medical follow-up, no specific psychological care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Shape Questionnaire	Average variation of the Body Shape Questionnaire (BSQ). BSQ is a 34 questions questionnaire, for each question the answer is 1 to 6, 1 for "never" and 6 for "always". (score ≥ 111, moderate body image concern)	Between inclusion and 12 months after.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change weight	Average weight loss in %, in the two arms.	Between inclusion day and Month 3
Change weight	Average weight loss in %, in the two arms.	Between Month 6 and Month 12
Body Image Assessment for Obesity questionnaire	Average variation in Body Image Assessment for Obesity, in each arm. The patient surrounds the figure that seems to closest to his or her current figure. And then he surrounds the figure he would like to achieve.This is a schematic representation of the body, from the thinnest silhouette in 1 to the widest in 18	Between inclusion day and Month 3
Body Image Assessment for Obesity questionnaire	Average variation in Body Image Assessment for Obesity questionnaire, in each arm.The patient surrounds the figure that seems to closest to his or her current figure. And then he surrounds the figure he would like to achieve. This is a schematic representation of the body, from the thinnest silhouette in 1 to the widest in 18	Between Month 6 and Month 12
Quality of Life, Obesity and Dietetics questionnaire assess quality of life	Average variation of the Quality of Life, Obesity and Dietetics, in each arm. This questionnaire consists of 36 questions that focus on the effects of the weight problem as experienced by the patient. For each question the patient can answer from 1 to 5: 1 always, 5 never.	Between inclusion day and Month 3
Quality of Life, Obesity and Dietetics questionnaire assess quality of life	Average variation of the Quality of Life, Obesity and Dietetics, in each arm. This questionnaire consists of 36 questions that focus on the effects of the weight problem as experienced by the patient. For each question the patient can answer from 1 to 5: 1 always, 5 never.	Between Month 6 and Month 12
Self-esteem	Average variation of the Rosenberg Self-Esteem Scale, in each arm. The scale represents an assessment of the person's overall self-esteem. The scale consists of 10 statements measured on a scale of 1 to 4: 1 "Totally disagree", 4 "Totally agree". The score is between 10 and 40. A score below 25 indicates very low self-esteem. A score between 25 and 31 indicates low self-esteem. A score between 31 and 34 indicates average self-esteem. A score between 34 and 39 indicates strong self-esteem. A score above 39 indicates very high self-esteem.	Between inclusion day and Month 3
Self-esteem	Average variation of the Rosenberg Self-Esteem Scale, in each arm.The scale represents an assessment of the person's overall self-esteem. The scale consists of 10 statements measured on a scale of 1 to 4: 1 "Totally disagree", 4 "Totally agree". The score is between 10 and 40. A score below 25 indicates very low self-esteem. A score between 25 and 31 indicates low self-esteem. A score between 31 and 34 indicates average self-esteem. A score between 34 and 39 indicates strong self-esteem. A score above 39 indicates very high self-esteem.	Between Month 6 and Month 12

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Body image; Virtual Reality Exposure Therapy; Dysmorphophobia
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Somatoform Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Body Dysmorphic Disorders
• Other Study ID Numbers: CHUBX 2021/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No