Brief Hypnosis Intervention for Palliative Care Patients and Their Relatives.

NCT05300126 | Completed DMC

• 1 other identifier: 2021-02193
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care; Hypnosis; Home

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Needs and integration assessed by semi structured interview

  through study completion, an average of 1 year

Study Arms (1)

Usual care

EXPERIMENTAL

No hypnosis session are proposed

Behavioral: Hypnosis

Interventions

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults ≥18 years
• followed by a mobile palliative care team
• interest in managing symptoms with hypnosis

You may not qualify if:

• inability to communicate in French without a translator
• severe cognitive impairment
• severe hearing impairment
• acute psychiatric or somatic decompensation.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Teike Lüthi Fabienne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Fabienne Teike Lüthi, PhD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 29, 2022
• Study Start: February 14, 2022
• Primary Completion: February 14, 2022
• Study Completion: December 30, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)