Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities

Study Overview
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Brief Summary
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There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. However, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.The investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. The investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.

Detailed Description
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Surveyors will conduct a first interview with patients (within an association La Fabrique Créative de Santé that provides free activities to chronically ill) , in order to collect data on emotion management and quality of life perception and to assess expectations regarding the activities. At the end of the interview, patients will be randomized in two groups. In arm 1, patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months. In arm 2, patients will follow the same pattern but will start activities 6 months later. After 6 months data on patients emotion management and quality of life perception will be collected again and interviews will be conducted regarding their overall satisfaction of the activities. Every six months during one year, data will be collected by mail or e-mail.

Official Title
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Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities

Conditions
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Emotion Management Skill, Educational Therapy, Creative and Physical Activities

Intervention / Treatment
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* Behavioral: patients choose one creative activity and one physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old and over Chronical illness Followed by a physician from Nantes University hospital Exclusion Criteria: Having already taken part in activities within the association La Fabrique Créative de Santé Mental illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months | Behavioral: patients choose one creative activity and one physical activity<br>* taking part in 2 activities (a creative one and a physical one)<br>|
| Active Comparator: control arm<br>patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during six months but they will start 6 months later after randomization | Behavioral: patients choose one creative activity and one physical activity<br>* taking part in 2 activities (a creative one and a physical one)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DERS questionnaire | differences between initial and final answers (after 6 months of intervention) scale composed of 36 items in 6 dimensions | 6 months after baseline interview | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life: comparison between baseline assessment and assessment 2 | With following scale of quality of life: SeiQoL | 6 months after baseline interview | 
| Changes in quality of life: comparison between baseline assessment and assessment 2 | With following scale of quality of life: EQ5D | 6 months after baseline interview | 
| Changes in quality of life: comparison between baseline assessment and assessment 2 | With following scale of quality of life: WHOQoL | 6 months after baseline interview | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic ill patients, Emotion management skill, Quality of Life