- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03959813
Evaluation of the Impact of Psychomotricity on the Patients Body Experience in Palliative Care (PSYCHOMOTPAL)
Palliative care is part of a comprehensive approach to the person, in the advanced phase of a serious illness. The purpose of this care is to relieve painful symptoms, to promote comfort and quality of life. In the context of a serious illness, the sick person is confronted with body modifications that have an impact on his body experience, that is, on his feelings and on the image that he has of his body.
Psychomotricity is a paramedical discipline that focuses on body-psyche links. The psychomotor therapist is authorized to take care of psychomotor disorders, as defined in the decree of competences. These psychomotor disorders appear in connection with the evolution of the serious illness and the presence of symptoms in these patients (ex: disorders of the tonic regulation, psychomotor disharmony, disorders of the representation of the body, etc.). In palliative care, the psychomotor therapist seeks to regulate these psychomotor disorders and thus to promote a more satisfying physical experience in the patient, through the use of different bodily approaches.
Several studies have shown the beneficial effects of touching and moving the body in cancer patients, but no work evaluating the effects of the psychomotor approach (involving various body mediations) on the body experience of patients with cancer in palliative situation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age greater than or equal to 18 years
- Man or woman
- Subject who has agreed to participate in the research and to use the data collected for research purposes
- Patient with solid cancer or hematological malignancy in palliative stage, that is to say a cancerous disease for which no curative treatment is no longer envisaged, with committed vital prognosis
- Hospitalize patient in palliative care unit
- Patient with indication of care in psychomotricity defined by the decree of competence Decree n ° 88-659 of May 6, 1988
- Patient with a minimum score of 4 on an item or a minimum score of 4 on several cumulative items (with a minimum of 2 on at least one of the items), on the ESAS scale, among the following themes: pain, anxiety, depression, uneasy feeling
Exclusion Criteria:
- Patient whose clinical condition (left to the decision of the investigator) does not allow to perform a psychomotor care and / or participate in a recorded interview (extreme fatigue, confusion, painful uncontrolled symptoms)
- Communication difficulties, patient not speaking or not understanding French
- Impossibility of giving the patient informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
- Patient under guardianship, curatorship
- Patient not affiliated to social welfare regime
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Realization of a questionnaire, based on the patient's global and physical feeling
Time Frame: 30 minutes before psychomotor care
|
questionnaire used to assess the impact of psychomotor care on the body experience of patients with advanced palliative care cancer, in both a physical and psychological dimension
|
30 minutes before psychomotor care
|
|
Realization of a questionnaire, based on the patient's global and physical feeling
Time Frame: 30 minutes after psychomotor care
|
questionnaire used to assess the impact of psychomotor care on the body experience of patients with advanced palliative care cancer, in both a physical and psychological dimension
|
30 minutes after psychomotor care
|
Collaborators and Investigators
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
- 7254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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