search
Back to results

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

Primary Purpose

Emotion Management Skill, Educational Therapy, Creative and Physical Activities

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
patients choose one creative activity and one physical activity
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Emotion Management Skill focused on measuring chronic ill patients, Emotion management skill, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

control arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in quality of life: comparison between baseline assessment and assessment 2
With following scale of quality of life: SeiQoL
Changes in quality of life: comparison between baseline assessment and assessment 2
With following scale of quality of life: EQ5D
Changes in quality of life: comparison between baseline assessment and assessment 2
With following scale of quality of life: WHOQoL

Full Information

First Posted
August 25, 2016
Last Updated
June 18, 2021
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02911207
Brief Title
Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities
Acronym
EvAd
Official Title
Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
December 4, 2018 (Actual)
Study Completion Date
December 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotion Management Skill, Educational Therapy, Creative and Physical Activities
Keywords
chronic ill patients, Emotion management skill, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
patients choose one creative activity and one physical activity
Intervention Description
taking part in 2 activities (a creative one and a physical one)
Primary Outcome Measure Information:
Title
DERS questionnaire
Description
differences between initial and final answers (after 6 months of intervention) scale composed of 36 items in 6 dimensions
Time Frame
6 months after baseline interview
Secondary Outcome Measure Information:
Title
Changes in quality of life: comparison between baseline assessment and assessment 2
Description
With following scale of quality of life: SeiQoL
Time Frame
6 months after baseline interview
Title
Changes in quality of life: comparison between baseline assessment and assessment 2
Description
With following scale of quality of life: EQ5D
Time Frame
6 months after baseline interview
Title
Changes in quality of life: comparison between baseline assessment and assessment 2
Description
With following scale of quality of life: WHOQoL
Time Frame
6 months after baseline interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs