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临床试验/NCT05300126
NCT05300126已完成不适用

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

Centre Hospitalier Universitaire Vaudois2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Expectations of hypnosis in terms of personal benefits assessed by VAS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Expectations of hypnosis in terms of personal benefits assessed by VAS

时间窗: 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)

Quality of life assessed by VAS

时间窗: Change from baseline quality of life at 4 weeks

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

Acceptance rate of the intervention assessed by descriptive numeric data

时间窗: 1 year

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

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

时间窗: 1 year

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

Comfort assessed by VAS

时间窗: Change from baseline comfort at 4 weeks

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

The main symptom intensity assessed by VAS

时间窗: 15 minutes

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

Symptom intensity assessed by Edmonton Symptom Assessment System

时间窗: Change from symptom intensity at 4 weeks

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

Satisfaction and needs assessed by semi structured interview

时间窗: 4 weeks

To globally understand the experience of the hypnosis intervention

次要结局

  • Needs and integration assessed by semi structured interview(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teike Luthi Fabienne

Principal investigator

Centre Hospitalier Universitaire Vaudois

研究点 (2)

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