- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03420690
Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families (ATREL)
Negative symptoms in cancer in palliative care, such as pain, can lead to a withdrawal that can lead to a form of social exclusion. Maintaining pre-illness relationships is often difficult for the patient, especially since he is often not available to relationships.
Art therapy defined as the exploitation of artistic potential in a therapeutic and humanitarian aim can contribute to the reduction of symptoms, to adaptation and to well-being. A recent review shows that positive affective states and meaningful social connections are important factors contributing to more effective adaptation to pain. Study hypothesis is that art therapy could play on these two factors.
The objective of the qualitative study is to measure, using a questionnaire, the indirect impact of art therapy sessions on parents, during support and after death, from a relational and emotional point of view.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Pierre-Bénite, France, 69495
- Centre Hospitalier Lyon Sud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Any major person who has accompanied a patient to the palliative care unit of the Lyon-Sud hospital
- Man or woman ;
- 18 years old or older;
- Death of the accompanied patient> 1 month;
- Number of art therapy session of the accompanied patient > 1;
- Having agreed to participate in the study;
- Not subject to a legal protection measure.
Exclusion Criteria:
- Nobody without the physical or mental abilities to respond to the questionnaire ;
- No one reading or speaking French.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Family of patient
|
After the administration of art therapy sessions (>1) and the death of patients (> 1 month), the intervention consists in submitting to families of patients a satisfaction questionnaire intended to evaluate the impact of art therapy session and in particular about their relationships.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall satisfaction with art therapy
Time Frame: 6 month
|
The primary endpoint is the item of overall satisfaction with art therapy session in 3 groups (VAS scale between 0 and 3, between 3 and 7 and between 7 and 10)
|
6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marilène FILBET, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL17_0626
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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