- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898749
Impact of Canine Mediation Practice in Psychomotor Therapy on Improving the Quality of Life in Adult Epileptic Patients. (MCP-Epi)
In addition to the search for new pharmaceutical or surgical solutions that could improve the therapeutic management of epileptic individuals, it is interesting to ask whether other complementary approaches, such as canine mediation in psychomotor therapy, could enhance the quality of life in this population.
However, there is currently no evidence indicating that exposure to animals through mediation sessions would be beneficial for epileptic individuals, particularly regarding their quality of life, anxiety, emotional management, or cognition (such as social cognition). In the absence of current data in this population, it seems pertinent to study the impact of this practice on people with epilepsy. Furthermore, beyond quality of life, it would be valuable to examine whether it also influences anxiety or the frequency of seizures in individuals with epilepsy (a phenomenon reported for epileptic individuals living with a pet dog or a service dog). Canine mediation could help better manage and regulate the emotions of epileptic individuals, as well as improve their self-esteem.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amelie Yavchitz
- Phone Number: +33148036454
- Email: ayavchitz@for.paris
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Person aged ≥ 18 years
- Presenting pharmacoresistant epilepsy according to the criteria of the International League Against Epilepsy
- Requiring psychomotor therapy sessions for one of the following indications:
Difficult emotional and relational management And/or global motor difficulties And/or body schema organization disorder And/or temporo-spatial disorder
- Explicit consent or no opposition to participation in the study by the patient and/or their legal representative or guardian
- Image rights consented by the patient and their legal representative or guardian, if applicable
- Hospitalization or residence at the Teppe Institute or at the FAM (Foyer d'Accueil Médicalisé) des 4 Jardins planned for at least 3 months
- Affiliated with or a beneficiary of a social security scheme
Exclusion Criteria:
- Fear or phobia of dogs
- Epileptic person benefiting from a legal protection measure other than guardianship or curatorship
- Person with insufficient cognitive abilities to respond to the questionnaires
- Pregnant or breastfeeding woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: canine mediation in psychomotor therapy
Group psychomotor therapy sessions combined with canine mediation (1 session per week for 10 weeks) |
Animal mediation consists of bringing an animal into contact with a specific audience to improve the mental or physical health of a person. The dog and beneficiaries interact through various activities, in which the animal participates, offered during the sessions. The dog plays a particularly important role as a mediator through the bonds it forms with the human, as well as a non-judgmental partner in interaction. The canine educator will be accompanied by a healthcare professional during interventions. The sessions are organized based on the expertise and suggestions of both professions (canine educator and psychomotor therapist). The canine educator will be a state-certified professional educator with a specialization in animal mediation. The dog used is trained by the educator, with two types of learning being worked on: emotions and "commands" on cue. |
|
Active Comparator: standard psychomotor therapy
Standard group psychomotor therapy sessions (1 session per week for 10 weeks)
|
standard sessions of psychomotor therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of quality of life
Time Frame: Day 0 and Day 7 after the end of the 10 sessions
|
Increase in the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) score of at least 5 points between inclusion and one week after the completion of the 10 sessions. The score of the QOLIE-31 (Quality of Life in Epilepsy Inventory-31) ranges from 0 to 100. A score of 0 represents the worst possible quality of life, while a score of 100 represents the best possible quality of life. |
Day 0 and Day 7 after the end of the 10 sessions
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMR_2024_8
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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