NCT06535763

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 23, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

self-hypnosisformationseniors

Outcome Measures

Primary Outcomes (1)

  • 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.

    Month 2 and month 6

Secondary Outcomes (1)

  • Effects of HAPNeSS method to professional practices

    Month 2 and month 6

Study Arms (1)

professional caregiver

nurse, care assistant, gerontological care assistant, psychologist, coordinating doctor, psychomotrician, occupational therapist in one of the 3 EHPADs in the study

Other: professional caregiver

Interventions

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.

professional caregiver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Bordeaux

Pessac, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseMental Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Officials

  • Marie FLOCCIA, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 2, 2024

Study Start

September 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations