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OpenTrials
Completed

NCT Number: NCT02911207

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patients choose one creative activity and one physical activity

Behavioral

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

Primary outcomes

  1. DERS questionnaire

    Time frame: 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 outcomes

  1. Changes in quality of life: comparison between baseline assessment and assessment 2

    Time frame: 6 months after baseline interview

    With following scale of quality of life: SeiQoL

  2. Changes in quality of life: comparison between baseline assessment and assessment 2

    Time frame: 6 months after baseline interview

    With following scale of quality of life: EQ5D

  3. Changes in quality of life: comparison between baseline assessment and assessment 2

    Time frame: 6 months after baseline interview

    With following scale of quality of life: WHOQoL

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: EvAd

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2016
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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