- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06535763
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 (HAPNeSS-E)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie FLOCCIA, MD
- Phone Number: +33556795679
- Email: marie.floccia@chu-bordeaux.fr
Study Contact Backup
- Name: Emma SALANNE
- Phone Number: +33556795679
- Email: emma.salanne@chu-bordeaux.fr
Study Locations
-
-
-
Pessac, France
- CHU de Bordeaux
-
Contact:
- Marie FLOCCIA, MD
- Email: marie.floccia@chu-bordeaux.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
professional caregiver
nurse, care assistant, gerontological care assistant, psychologist, coordinating doctor, psychomotrician, occupational therapist in one of the 3 EHPADs in the study
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Month 2 and month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of HAPNeSS method to professional practices
Time Frame: Month 2 and month 6
|
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).
|
Month 2 and month 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marie FLOCCIA, MD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2023/87
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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