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

Creative and Physical Activities Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911207
• Other study ID #: RC16_0011
• Status: Completed
• Phase: N/A
• Start date: August 29, 2016
• Est. completion date: December 4, 2018

Study information

• Verified date: June 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Creative and Physical Activities
• Educational Therapy
• Emotion Management Skill

Intervention

Behavioral:
• patients choose one creative activity and one physical activity
taking part in 2 activities (a creative one and a physical one)

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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