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Completed

NCT Number: NCT05300126

Brief Hypnosis Intervention for Palliative Care Patients and Their Relatives.

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.

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Key information

Conditions

Palliative Care Home Hypnosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teike Lüthi Fabienne

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypnosis

Behavioral

Four sessions of 15 minute hypnosis, based on standardised script, focused on symptom management for the patients and of resource development for relatives.

Primary outcomes

  1. Expectations of hypnosis in terms of personal benefits assessed by VAS

    Time frame: Change from baseline hypnosis expectations at 4 weeks

    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)

  2. Acceptance rate of the intervention assessed by descriptive numeric data

    Time frame: 1 year

    How many times the intervention was proposed and how many patients and relatives were interested in and had participated

  3. Number of sessions carried out and their duration assessed by descriptive numeric data

    Time frame: 1 year

    For each patient and relatives the number of sessions and duration of each session is collected

  4. Symptom intensity assessed by Edmonton Symptom Assessment System

    Time frame: Change from symptom intensity at 4 weeks

    Nine symptoms are assessed by VAS: 0: no symptom at all to 10: maximal intensity

  5. Quality of life assessed by VAS

    Time frame: Change from baseline quality of life at 4 weeks

    The global quality of life is assessed by VAS 0: minimal to 10: maximal

  6. Comfort assessed by VAS

    Time frame: Change from baseline comfort at 4 weeks

    The global comfort is assessed by VAS 0: minimal to 10: maximal

  7. The main symptom intensity assessed by VAS

    Time frame: 15 minutes

    The main symptom present before the hypnosis session is assessed by VAS: 0: no symptom at all to 10: maximal intensity

  8. Satisfaction and needs assessed by semi structured interview

    Time frame: 4 weeks

    To globally understand the experience of the hypnosis intervention

Secondary outcomes

  1. Needs and integration assessed by semi structured interview

    Time frame: through study completion, an average of 1 year

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: HypnoPal

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2022
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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