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

NCT ID: NCT02911207

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-29
• Study Completion Date: 2018-12-04

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.

Conditions

Emotion Management Skill; Educational Therapy; Creative and Physical Activities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention arm

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

Group Type: EXPERIMENTAL

patients choose one creative activity and one physical activity

Intervention Type: BEHAVIORAL

taking part in 2 activities (a creative one and a physical one)

control arm

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

Group Type: ACTIVE_COMPARATOR

patients choose one creative activity and one physical activity

Intervention Type: BEHAVIORAL

taking part in 2 activities (a creative one and a physical one)

Interventions

patients choose one creative activity and one physical activity

taking part in 2 activities (a creative one and a physical one)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes University Hospital

Nantes, Loire-Atlantique, France

Countries

France

References

Le Rhun A, Caillet P, Lebeaupin M, Duval M, Guilmault L, Anthoine E, Borghi G, Leclere B, Moret L. Mind-body and art therapies impact on emotional regulation in patients with chronic diseases: a pragmatic mixed-methods randomized controlled trial. BMC Complement Med Ther. 2023 Sep 28;23(1):344. doi: 10.1186/s12906-023-04173-8.

Reference Type: DERIVED

PMID: 37770881 (View on PubMed)

Other Identifiers

RC16_0011

Identifier Type: -

Identifier Source: org_study_id