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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03118921
Other study ID # REVAM
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 20, 2017
Est. completion date October 31, 2019

Study information

Verified date December 2021
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of the tolerance and acceptability of the virtual representation of its body image.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 40 Years
Eligibility Inclusion Criteria: - Women, aged between 16 and 40 - Post-puberty - Pure restrictive anorexia nervosa, diagnosis by the DSM-V - BMI <17.5 - Patient attending an outpatient clinic at the Bohars Psychiatric Hospital in France - Having signed the Informed Consent Form - For minor patients, signing the form of informed consent of both parents Exclusion Criteria: - Associated eating disorder (bulimia, or the binge eating / purging form of anorexia nervosa), - Psychiatric disorders (characterized depressed, anxiety disorder) - Neurological Disorders - Mental retardation - Abuse or addiction to alcohol - Abuse or dependence on psychoactive substances in the previous year. - Patient with a protective justice measure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual reality
The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software.

Locations

Country Name City State
France CHRU Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-questionnaire assessing tolerance Patients will have to respond to a self-administered questionnaire assessing tolerance Day 15
Primary Self-questionnaire assessing acceptability Patients will have to respond to a self-administered questionnaire assessing acceptability Day 15
Secondary Feeling of presence Patients will respond to a self-questionnaire of feeling of presence Day 15
Secondary Subjective experience by EDI-2 questionnaire Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire. Day 15
Secondary Subjective experience by BSQ questionnaire Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire. Day 15
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