Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02911207
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2016-08-25
Brief Title:
Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients Benefiting From Creative and Physical Activities
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients Benefiting From Creative and Physical Activities
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EvAd
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 psychologyThe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None