Sensory Workshops and Anorexia Nervosa

Anorexia Clinical Trial

Official title:

Prospective Evaluation of a Year of Therapeutic Impact Sensory Workshops on Body Mass Index in Anorexia Adolescent Mental

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02793102
• Other study ID #: 14-HPNCL-11
• Status: Withdrawn
• Phase: N/A
• First received: June 3, 2016
• Last updated: June 3, 2016
• Start date: September 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2016
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

In the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.

Description:

As part of the unit that specializes in eating disorders in adolescents, we see patients decreased taste and smell sensory abilities. Since 2006, we have implemented various sensory workshops: olfactory, tactile-kinesthetic and auditory. The establishment of this therapeutic practice that is centered on oral sphere and all respect, it was observed a decrease of 30% of the length of hospitalization. All the data we currently have in the field, suggests a rehabituation food odors and facilitate the recall of memories related to food in anorexic patients. However in the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of anorexia nervosa according to DMS IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria.

• Follow Outpatient care or hospitalization

• Able to respond to the clinical evaluation questionnaires

• Affiliated to the social security system

• Consentement Informed of the legal representative and the patient

Exclusion Criteria:

• Somatic comorbidity associated diabetes, celiac disease, brain tumor.

• Intolerance Odors, predisposition to develop asthma and / or respiratory allergies.

• Pathologie Chronic of nose and sinus.

• Hyposmic Or anosmic.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anorexia

Intervention

Other:
• Olfactory workshop
Twenty odorants are selected: 10 evoke a food (including 5 pleasant and unpleasant 5) and 10 suggest a non-food source
• Somesthesia workshop
Kinesthetic time or time for moving the body (30 min), and kinesthetic sensations (duration 10 min), and Talk Time
• Auditory workshop
Twenty extracts of music tracks (30 seconds each) are built in the same fashion as those used during the workshops, but are different.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the impact of sensory workshops on BMI Body Mass Indexat 6 months and 12 months	The primary endpoint is the M6 and increase maintenance M12 BMI Body Mass Index to	Comparaison to baseline and 6 month after and maintenance at month 12	No