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

Not Applicable

Completed

• Conditions: Creative and Physical Activities; Emotion Management Skill; Educational Therapy
• Interventions: Behavioral: patients choose one creative activity and one physical activity

• Registration Number: NCT02911207
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

1. 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.

2. 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.

3. In arm 2, patients will follow the same pattern but will start activities 6 months later.

4. 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.

5. Every six months during one year, data will be collected by mail or e-mail.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-25
• Study Start: 2016-08-29
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2018-12-04
• Study Completion: 2018-12-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 18 years old and over
• Chronical illness
• Followed by a physician from Nantes University hospital

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Exclusion Criteria

• Having already taken part in activities within the association "La Fabrique Créative de Santé"
• Mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	patients choose one creative activity and one physical activity	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
Intervention arm	patients choose one creative activity and one physical activity	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

Primary Outcome Measures

Name	Time	Method
DERS questionnaire	6 months after baseline interview	differences between initial and final answers (after 6 months of intervention) scale composed of 36 items in 6 dimensions

Secondary Outcome Measures

Name	Time	Method
Changes in quality of life: comparison between baseline assessment and assessment 2	6 months after baseline interview	With following scale of quality of life: WHOQoL

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France