Brief Hypnosis Intervention for Palliative Care Patients and Their Relatives. (HypnoPal)

HypnoPal : a Mixed Method Study of a Home Based 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.

Study Overview

• Status: Completed
• Conditions: Palliative Care; Hypnosis; Home
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabienne Teike Lüthi, PhD; Phone Number: +41 79 556 80 89; Email: Fabienne.Teike-luethi@chuv.ch
• Study Contact Backup: Name: Anca Sterie, PhD; Email: anca-cristina.sterie@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Teike Lüthi Fabienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual care; No hypnosis session are proposed	Behavioral: Hypnosis; Four sessions of 15 minute hypnosis, based on standardised script, focused on symptom management for the patients and of resource development for relatives.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Fabienne Teike Lüthi, PhD, Lausanne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021-02193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No