Palliative CarePSYCHOMOTPALNCT03959813
Evaluation of the Impact of Psychomotricity on the Patients Body Experience in Palliative Care
An observational study of Palliative Care, run by University Hospital, Strasbourg, France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Psychomotricity by touching and passive mobilizations
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized in palliative care units
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Conditions
- Palliative Care
- Being tested
- Psychomotricity by touching and passive mobilizations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychomotricity by touching and passive mobilizationsOther
The patient will have a first psychomotricity session. It will be carried out remotely from the drug catches to avoid bias induced by their administration having effects on the symptoms studied.
Before and after the session, two evaluations will be offered to the patient and performed by a nurse:
- A questionnaire, based on the physical experience,
- The ESAS scale will be administered to the patient to assess the importance of symptoms (pain, depression, anxiety, discomfort) During the session, a touch treatment will be offered to promote awareness of the body. Passive mobilizations at the level of the members and the axis will then be proposed, to promote the pleasure of being in motion. A touch treatment will be done again to promote relaxation.
A questionnaire can be offered to the patient after 4 sessions to assess his perception of psychomotricity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Realization of a questionnaire, based on the patient's global and physical feeling
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
Measured: 30 minutes before psychomotor care
Realization of a questionnaire, based on the patient's global and physical feeling
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
Measured: 30 minutes after psychomotor care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Sep 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: the ethics committee has not accepted the extension
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959813
- Sponsor's protocol ID
- 7254
- Acronym
- PSYCHOMOTPAL
- Status last verified
- Sep 2021
- First submitted
- 6 May 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Psychomotricity on the Patients Body Experience in Palliative Care
- ClinicalTrials.gov ID
- NCT03959813
- Acronym / sponsor ID
- PSYCHOMOTPAL / 7254
- Conditions
- Palliative Care
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the ethics committee has not accepted the extension
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in palliative care units
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychomotricity by touching and passive mobilizationsThe patient will have a first psychomotricity session. It will be carried out remotely from the drug catches to avoid bias induced by their administration having effects on the symptoms studied. Before and after the session, two evaluations will be offered to the patient and performed by a nurse: * A questionnaire, based on the physical experience, * The ESAS scale will be administered to the patient to assess the importance of symptoms (pain, depression, anxiety, discomfort) During the session, a touch treatment will be offered to promote awareness of the body. Passive mobilizations at the level of the members and the axis will then be proposed, to promote the pleasure of being in motion. A touch treatment will be done again to promote relaxation. A questionnaire can be offered to the patient after 4 sessions to assess his perception of psychomotricity. | Other | – |
Primary outcome
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Realization of a questionnaire, based on the patient's global and physical feeling (time frame: 30 minutes before psychomotor care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.