Brief Hypnosis Intervention for Palliative Care Patients and Their Relatives.

Study Overview
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Brief Summary
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The study objective is to assess the feasibility of hypnosis sessions for palliative care patients in home care and of their relatives. The intervention consists of four 15-minute hypnosis sessions for the patients and for one family member, taking place at the patient's home. Recordings will be given to practice self-hypnosis.

Detailed Description
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The primary outcome of this study is to assess the feasibility of a home based hypnosis intervention, targeting the management of symptoms (e.g. pain, anxiety) of palliative care patients and the reinforcement of a positive skill for their relatives (e.g. acceptance, relaxation), as well as the development of their respective self-hypnosis practice. The two secondary outcomes are: i) to understand what the needs of palliative care patients and their relatives are in relation to complementary medicine and ii) to understand the process of integration of complementary medicine into usual care by looking at how this takes place for the participants to the intervention as well as for other palliative care patients who resort to using complementary medicine (not limited to hypnosis). This is a mixed-methods study combining quantitative and qualitative data in a convergent design. The convergent design, derived from the pragmatic paradigm, involves the independent collection and analysis of quantitative and qualitative data. The results are then merged in order to compare and/or combine them and thus provide a broader understanding of the issue being studied. For the intervention, participants will be recruited by a community mobile palliative care team. They will be screened by the study team to ensure they fulfil the inclusion criteria. If eligible and after informed consent is obtained, an assessment of the cognitive function will be performed. The patients will then recruit one of their relatives for participation to the study. For the secondary outcomes, participants will be healthcare professionals working in palliative care setting and using complementary medicine in their daily practice and also patients using complementary medicine but who do not participate at the interventional part of this study.

Official Title
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HypnoPal : a Mixed Method Study of a Home Based Hypnosis Intervention for Palliative Care Patients and Their Relatives

Conditions
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Palliative Care, Hypnosis, Home

Intervention / Treatment
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* Behavioral: Hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : adults ≥18 years followed by a mobile palliative care team expressed symptom such as: pain, dyspnea, sleep disturbance or anxiety at a score of ≥ 3/10 at inclusion interest in managing symptoms with hypnosis Exclusion Criteria : inability to communicate in French without a translator severe cognitive impairment severe hearing impairment acute psychiatric or somatic decompensation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis<br> | Behavioral: Hypnosis<br>* Four sessions of 15 minute hypnosis, based on standardised script, focused on symptom management for the patients and of resource development for relatives.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expectations of hypnosis in terms of personal benefits assessed by VAS | Measured at Baseline - Question: how well do you expect this treatment to work for you (VAS: 0: no effect at all to 10: full relief) | Change from baseline hypnosis expectations at 4 weeks | 
| Acceptance rate of the intervention assessed by descriptive numeric data | How many times the intervention was proposed and how many patients and relatives were interested in and had participated | 1 year | 
| Number of sessions carried out and their duration assessed by descriptive numeric data | For each patient and relatives the number of sessions and duration of each session is collected | 1 year | 
| Symptom intensity assessed by Edmonton Symptom Assessment System | Nine symptoms are assessed by VAS: 0: no symptom at all to 10: maximal intensity | Change from symptom intensity at 4 weeks | 
| Quality of life assessed by VAS | The global quality of life is assessed by VAS 0: minimal to 10: maximal | Change from baseline quality of life at 4 weeks | 
| Comfort assessed by VAS | The global comfort is assessed by VAS 0: minimal to 10: maximal | Change from baseline comfort at 4 weeks | 
| The main symptom intensity assessed by VAS | The main symptom present before the hypnosis session is assessed by VAS: 0: no symptom at all to 10: maximal intensity | 15 minutes | 
| Satisfaction and needs assessed by semi structured interview | To globally understand the experience of the hypnosis intervention | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needs and integration assessed by semi structured interview | To assess the needs of this specific population regarding the integrative medicine and the integration of complementary medicine into routine care by interviewing professionals, patients and relatives | through study completion, an average of 1 year |