ObesityBARIAREVNCT05460104
Impact of the Use of VERT on Body Image After Bariatric Surgery
A study testing Experimental in people with Obesity and Bariatric Surgery Candidate, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Mar 2024to 19 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH de Libourne - Hôpital Robert BOULIN
Libourne, 33500
CHU de Bordeaux - Hopital Haut-Lévêque
Pessac, 33604
About this study
Official title: 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).
Read the 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.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- Experimental, Control
- Keywords
- Virtual Reality Exposure Therapy, Body image, Dysmorphophobia
- Medical subject headings
- Obesity, Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDevice
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.
ControlOther
Standard care is medical follow-up, no specific psychological care.
| Study group | Role | What they receive |
|---|---|---|
| Expérimental | Experimental | Virtual Reality Exposure Therapy will be realised. Receives: Device: Experimental |
| Control | Active comparator | Standard care without VRET Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Between inclusion and 12 months after.
Secondary outcomes (8)
Change weight
Average weight loss in %, in the two arms.
Measured: Between inclusion day and Month 3
Change weight
Average weight loss in %, in the two arms.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start12 Mar 2024
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460104
- Sponsor's protocol ID
- CHUBX 2021/37
- Acronym
- BARIAREV
- Status last verified
- Jan 2026
- First submitted
- 15 Jun 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Virtual Reality Exposure Therapy on Body Image After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05460104
- Acronym / sponsor ID
- BARIAREV / CHUBX 2021/37
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- Virtual Reality Exposure Therapy, Body image, Dysmorphophobia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expérimental | Experimental | Device: ExperimentalVirtual Reality Exposure Therapy will be realised. |
| Control | Active comparator | Other: ControlStandard care without VRET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalVirtual 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. | Device | Expérimental |
| ControlStandard care is medical follow-up, no specific psychological care. | Other | Control |
Primary outcome
Body Shape Questionnaire
Time frame: Between inclusion and 12 months after.
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)
8 secondary outcomes
Change weight
Time frame: Between inclusion day and Month 3
Change weight
Time frame: Between Month 6 and Month 12
Body Image Assessment for Obesity questionnaire
Time frame: Between inclusion day and Month 3
Body Image Assessment for Obesity questionnaire
Time frame: Between Month 6 and Month 12
Quality of Life, Obesity and Dietetics questionnaire assess quality of life
Time frame: Between inclusion day and Month 3
Quality of Life, Obesity and Dietetics questionnaire assess quality of life
Time frame: Between Month 6 and Month 12
Self-esteem
Time frame: Between inclusion day and Month 3
Self-esteem
Time frame: Between Month 6 and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Obesity and Bariatric Surgery Candidate, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Shape Questionnaire (time frame: Between inclusion and 12 months after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.