Clinical trial NCT05300126: Brief Hypnosis Intervention for Palliative Care Patients and Their Relatives.
Official title: HypnoPal : a Mixed Method Study of a Home Based Hypnosis Intervention for Palliative Care Patients and Their Relatives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Hypnosis
Home
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Expectations of hypnosis in terms of personal benefits assessed by VAS
timeFrame: Change from baseline hypnosis expectations at 4 weeks
measure: Acceptance rate of the intervention assessed by descriptive numeric data
timeFrame: 1 year
measure: Number of sessions carried out and their duration assessed by descriptive numeric data
timeFrame: 1 year
measure: Symptom intensity assessed by Edmonton Symptom Assessment System
timeFrame: Change from symptom intensity at 4 weeks
measure: Quality of life assessed by VAS
timeFrame: Change from baseline quality of life at 4 weeks
measure: Comfort assessed by VAS
timeFrame: Change from baseline comfort at 4 weeks
measure: The main symptom intensity assessed by VAS
timeFrame: 15 minutes
measure: Satisfaction and needs assessed by semi structured interview
timeFrame: 4 weeks
Secondary outcomes:
measure: Needs and integration assessed by semi structured interview
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Teike Lüthi Fabienne
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Fabienne Teike Lüthi, PhD
role: PRINCIPAL_INVESTIGATOR
References: