Sensory Workshops and Anorexia Nervosa

June 3, 2016 updated by: Fondation Lenval

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Olfactory workshop + Somesthesia workshop
Olfactory workshop, Twenty odorants. Somesthesia workshop, time for moving the body, Talk Time
Other: Olfactory workshop
Twenty odorants are selected: 10 evoke a food (including 5 pleasant and unpleasant 5) and 10 suggest a non-food source
Other: Somesthesia workshop
Kinesthetic time or time for moving the body (30 min), and kinesthetic sensations (duration 10 min), and Talk Time
EXPERIMENTAL: Auditory workshop + Somesthesia workshop
Auditory workshop, Twenty extracts of music tracks. Somesthesia workshop, time for moving the body, Talk Time
Other: Somesthesia workshop
Kinesthetic time or time for moving the body (30 min), and kinesthetic sensations (duration 10 min), and Talk Time
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the impact of sensory workshops on BMI Body Mass Indexat 6 months and 12 months
Time Frame: Comparaison to baseline and 6 month after and maintenance at month 12
The primary endpoint is the M6 and increase maintenance M12 BMI Body Mass Index to <or = 2.6kg / m2
Comparaison to baseline and 6 month after and maintenance at month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Lenval

Investigators

  • Principal Investigator: Florence ASKENAZY, MD, Fondation Lenval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (ESTIMATE)

June 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-HPNCL-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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