Palliative CareHypnoPalNCT05300126
Brief Hypnosis Intervention for Palliative Care Patients and Their Relatives.
A study testing Hypnosis in people with Palliative Care and Hypnosis, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Hypnosis, Home
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Feb 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- inability to communicate in French without a translator
- severe cognitive impairment
- severe hearing impairment
- acute psychiatric or somatic decompensation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Palliative Care, Hypnosis, Home
- Being tested
- Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
Four sessions of 15 minute hypnosis, based on standardised script, focused on symptom management for the patients and of resource development for relatives.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Experimental | No hypnosis session are proposed Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 15 minutes
Satisfaction and needs assessed by semi structured interview
To globally understand the experience of the hypnosis intervention
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start14 Feb 2022
- Primary completion14 Feb 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teike Luthi Fabienne, Centre Hospitalier Universitaire Vaudois
- Investigators
- Fabienne Teike Lüthi, PhD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300126
- Sponsor's protocol ID
- 2021-02193
- Acronym
- HypnoPal
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HypnoPal : a Mixed Method Study of a Home Based Hypnosis Intervention for Palliative Care Patients and Their Relatives
- ClinicalTrials.gov ID
- NCT05300126
- Acronym / sponsor ID
- HypnoPal / 2021-02193
- Conditions
- Palliative Care, Hypnosis, Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual care | Experimental | Behavioral: HypnosisNo hypnosis session are proposed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- inability to communicate in French without a translator
- severe cognitive impairment
- severe hearing impairment
- acute psychiatric or somatic decompensation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisFour sessions of 15 minute hypnosis, based on standardised script, focused on symptom management for the patients and of resource development for relatives. | Behavioural | Usual care |
Primary outcome
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)
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
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
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
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
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
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
Satisfaction and needs assessed by semi structured interview
Time frame: 4 weeks
To globally understand the experience of the hypnosis intervention
1 secondary outcome
Needs and integration assessed by semi structured interview
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Teike Lüthi, PhD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Palliative Care and Hypnosis, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expectations of hypnosis in terms of personal benefits assessed by VAS (time frame: Change from baseline hypnosis expectations at 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.