Alzheimer DiseaseHAPNeSS-ENCT06535763
Impact and Influence of the Use of Hypnosis Adapted to People With Severe Stage Neurocognitive Disorder (HAPNeSS) on the Professional Practices of EHPAD (Establishment for Dependent Elderly People) Caregivers With Elderly Residents
An observational study of Alzheimer Disease and Behavior Disorders, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of this study is to propose a non-anxiety-inducing method of managing behavioral disorders for patients and healthcare professionals. The main objective of this study is to evaluate the implementation, use and effects of HAPNeSS (Hypnosis Adapted to People with Severe Neurocognitive Disorders) training on the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Behavior Disorders
- What is being tested?
- professional caregiver
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Mar 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: EHPAD staff meeting : * Nurses, care assistants, gerontological care assistants, psychologists, coordinating physicians, psychomotor therapists, occupational therapists; with more than one year's experience in the structure.
Who may be able to join
- EHPAD staff meeting the following criteria will be included in the study:
- Nurses, care assistants, gerontological care assistants, psychologists, coordinating physicians, psychomotor therapists, occupational therapists;
- More than one year's experience in the structure.
- The study will examine the individual perceptions of EHPAD professionals of patients meeting the following criteria:
- Be a resident of an EHPAD ;
- suffering from a moderately severe or severe major neurocognitive disorder;
- over 75 years of age.
Who cannot join
- EHPAD professionals will not be included:
- Not fluent in French,
- Not wishing to be trained in hypnosis.
- The individual perception of EHPAD professionals of patients meeting these criteria will not be questioned in the study:
- Minor neurocognitive impairment, major neurocognitive impairment at a mild or moderate stage, or no cognitive impairment;
- under 75 years of age.
Trial locations and contacts
1 site in 1 country.
France1 site
Chu de Bordeaux
Pessac
Marie FLOCCIA, MD, marie.floccia@chu-bordeaux.fr
About this study
The aim of this study is to propose a non-anxiety-inducing method of managing behavioral disorders for patients and healthcare professionals. The main objective of this study is to evaluate the implementation, use and effects of HAPNeSS (Hypnosis Adapted to People with Severe Neurocognitive Disorders) training on the management of residents aged over 75 with moderately severe to severe Alzheimer's disease or a related disorder, who may present behavioral disorders, with caregivers working in EHPAD.
Read the detailed description
The HAPNeSS method would offer caregivers the opportunity to find solutions to difficulties encountered (behavioral disorders, difficult care, etc.), to move away from pure technicality to reinvest in the relationship with the patient, and to find soothing, respectful and benevolent channels of communication. The aim of this study is to evaluate the effects of HAPNeSS (Hypnosis Adapted to People with Severe Neurocognitive Disorders) training on the care of residents over 75 with moderately severe to severe Alzheimer's disease or related disorders, who may present behavioral problems.
But also to measure, within each establishment, the effects of the HAPNeSS method, on the professional practices of caregivers (actions implemented, execution of missions, relationship with residents...) and to gather their feelings. These objectives therefore aim to collect and evaluate the effects of this method on the relationship between patients and caregivers, as well as on the latter's QWL. To achieve this, the research team organized 4 visits to the EHPADs participating in the study, spread over 6 months. Training takes place over 3 and then 2 days. Before and after the training, a visit at the beginning and end of the study will enable the scales to be administered and the interviews to be conducted. The data collected will be the subject of a mixed statistical analysis. Throughout the study, the research team will monitor the learning and development of each care professional.
- Conditions
- Alzheimer Disease, Behavior Disorders
- Being tested
- professional caregiver
- Keywords
- self-hypnosis, formation, seniors
- Medical subject headings
- Alzheimer Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
professional caregiverOther
Care professionals will be questioned using a self-administered Quality of Life at Work scale, as well as a second scale (before and after training, with one test per day for 3 consecutive working days) asking about the number of work situations involving behavioral disorders in the residents under their care, and how they use the HAPNeSS method to deal with these situations.
The effects of the HAPNeSS method on caregivers' professional practices (actions taken, performance of tasks, relations with residents, etc.) and their feelings on the subject, will be collected in two semi-structured interviews (with half the participants selected at random) conducted before and after the training course by the research team's occupational psychologist.
| Study group | Role | What they receive |
|---|---|---|
| professional caregiver | nurse, care assistant, gerontological care assistant, psychologist, coordinating doctor, psychomotrician, occupational therapist in one of the 3 EHPADs in the study Receives: Other: professional caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of HAPNeSS on the management of work situations involving behavioral disorders.
Number of work situations which the carer feels he/she has had difficulty managing, involving a resident with a neurocognitive disorder and behavioural problems.
Measured: Month 2 and month 6
Secondary outcomes (1)
Effects of HAPNeSS method to professional practices
Scale QENA, minimum value 69 and maximum value 276. Analysis of feelings and impressions of professionals will be obtained from the analysis of the semi-directed interviews (qualitative analysis).
Measured: Month 2 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie FLOCCIA, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535763
- Sponsor's protocol ID
- CHUBX 2023/87
- Acronym
- HAPNeSS-E
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Influence of the Use of Hypnosis Adapted to People With Severe Stage Neurocognitive Disorder (HAPNeSS) on the Professional Practices of EHPAD (Establishment for Dependent Elderly People) Caregivers With Elderly Residents
- ClinicalTrials.gov ID
- NCT06535763
- Acronym / sponsor ID
- HAPNeSS-E / CHUBX 2023/87
- Conditions
- Alzheimer Disease, Behavior Disorders
- Keywords
- self-hypnosis, formation, seniors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 2 Aug 2024 (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 aim of this study is to propose a non-anxiety-inducing method of managing behavioral disorders for patients and healthcare professionals. The main objective of this study is to evaluate the implementation, use and effects of HAPNeSS (Hypnosis Adapted to People with Severe Neurocognitive Disorders) training on the management of residents aged over 75 with moderately severe to severe Alzheimer's disease or a related disorder, who may present behavioral disorders, with caregivers working in EHPAD.
Detailed description
The HAPNeSS method would offer caregivers the opportunity to find solutions to difficulties encountered (behavioral disorders, difficult care, etc.), to move away from pure technicality to reinvest in the relationship with the patient, and to find soothing, respectful and benevolent channels of communication. The aim of this study is to evaluate the effects of HAPNeSS (Hypnosis Adapted to People with Severe Neurocognitive Disorders) training on the care of residents over 75 with moderately severe to severe Alzheimer's disease or related disorders, who may present behavioral problems.
But also to measure, within each establishment, the effects of the HAPNeSS method, on the professional practices of caregivers (actions implemented, execution of missions, relationship with residents...) and to gather their feelings. These objectives therefore aim to collect and evaluate the effects of this method on the relationship between patients and caregivers, as well as on the latter's QWL. To achieve this, the research team organized 4 visits to the EHPADs participating in the study, spread over 6 months. Training takes place over 3 and then 2 days. Before and after the training, a visit at the beginning and end of the study will enable the scales to be administered and the interviews to be conducted. The data collected will be the subject of a mixed statistical analysis. Throughout the study, the research team will monitor the learning and development of each care professional.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| professional caregiver | – | Other: professional caregivernurse, care assistant, gerontological care assistant, psychologist, coordinating doctor, psychomotrician, occupational therapist in one of the 3 EHPADs in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- EHPAD staff meeting : * Nurses, care assistants, gerontological care assistants, psychologists, coordinating physicians, psychomotor therapists, occupational therapists; with more than one year's experience in the structure.
Key inclusion criteria (7 listed)
- Nurses, care assistants, gerontological care assistants, psychologists, coordinating physicians, psychomotor therapists, occupational therapists;
- More than one year's experience in the structure.
- The study will examine the individual perceptions of EHPAD professionals of patients meeting the following criteria:
- Be a resident of an EHPAD ;
- suffering from a moderately severe or severe major neurocognitive disorder;
Key exclusion criteria (6 listed)
- Not fluent in French,
- Not wishing to be trained in hypnosis.
- The individual perception of EHPAD professionals of patients meeting these criteria will not be questioned in the study:
- Minor neurocognitive impairment, major neurocognitive impairment at a mild or moderate stage, or no cognitive impairment;
- under 75 years of age.
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 |
|---|---|---|
| professional caregiverCare professionals will be questioned using a self-administered Quality of Life at Work scale, as well as a second scale (before and after training, with one test per day for 3 consecutive working days) asking about the number of work situations involving behavioral disorders in the residents under their care, and how they use the HAPNeSS method to deal with these situations. The effects of the HAPNeSS method on caregivers' professional practices (actions taken, performance of tasks, relations with residents, etc.) and their feelings on the subject, will be collected in two semi-structured interviews (with half the participants selected at random) conducted before and after the training course by the research team's occupational psychologist. | Other | professional caregiver |
Primary outcome
Impact of HAPNeSS on the management of work situations involving behavioral disorders.
Time frame: Month 2 and month 6
Number of work situations which the carer feels he/she has had difficulty managing, involving a resident with a neurocognitive disorder and behavioural problems.
1 secondary outcome
Effects of HAPNeSS method to professional practices
Time frame: Month 2 and month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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.
Marie FLOCCIA, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Behavior Disorders, run by University Hospital, Bordeaux at 1 site in France.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Aug 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie FLOCCIA, MD (+33556795679, marie.floccia@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of HAPNeSS on the management of work situations involving behavioral disorders. (time frame: Month 2 and month 6). 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 2 Aug 2024.