ClinicalTrials.gg
Active, not recruitingNCT05460104BARIAREVUpdated Jan 15, 2026

Impact of the Use of VERT on Body Image After Bariatric Surgery

An interventional study of Experimental and Control in Obesity and Bariatric Surgery Candidate, sponsored by University Hospital, Bordeaux. Active, not recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity
  • Bariatric Surgery Candidate

Keywords

  • Virtual Reality Exposure Therapy
  • Body image
  • Dysmorphophobia
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 11 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Expérimental

    Virtual Reality Exposure Therapy will be realised.

    Device: Experimental

  • Active comparator
    Control

    Standard care without VRET

    Other: Control

Interventions

  • DeviceExperimental

    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.

  • OtherControl

    Standard care is medical follow-up, no specific psychological care.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Between inclusion and 12 months after.

Secondary outcomes

  1. Change weight

    Average weight loss in %, in the two arms.

    Time frame: Between inclusion day and Month 3

  2. Change weight

    Average weight loss in %, in the two arms.

    Time frame: Between Month 6 and Month 12

  3. 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

    Time frame: Between inclusion day and Month 3

  4. 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

    Time frame: Between Month 6 and Month 12

  5. 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.

    Time frame: Between inclusion day and Month 3

  6. 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.

    Time frame: Between Month 6 and Month 12

  7. 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.

    Time frame: Between inclusion day and Month 3

  8. 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.

    Time frame: Between Month 6 and Month 12

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Study locations

2 sites
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 33 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2022
First posted
Jul 15, 2022
StartActual
Mar 12, 2024
Primary completionEst.
Dec 19, 2026
CompletionEst.
Dec 19, 2026
Last update
Jan 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05460104
Responsible party
Sponsor
First posted
Jul 15, 2022
Start date
Mar 12, 2024
Primary completion
Dec 19, 2026 (estimated)
Completion
Dec 19, 2026 (estimated)
Last update
Jan 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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