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HYPNOSTRESS: Medical Hypnosis and Stress Reduction in Hospitalization

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05760014
Collaborator
(none)
60
Enrollment
8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Patients with chronic diseases, especially rare diseases with uncertain diagnoses, have a representation of their disease and an experience of their hospitalization that is sometimes traumatic, distressing and painful. Patients hospitalized can benefit from non-medicinal techniques, such as medical hypnosis, which could improve the perceived stress in these patients and thus optimize the hospitalization experience. The aim of this study is to evaluate the impact of medical hypnosis in reducing stress and improving the experience of hospitalization comparing two groups : a group (cases) benefiting from an hypnotic technic " the place of safety " and a control group without intervention during hospitalization

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Interest of Medical Hypnosis in Reducing Stress and Improving the Experience of Hospitalization in Internal Medicine
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    CAS patients

    CAS patients with a conventional follow-up who will benefit from the hypnosis technique known as "Place of Safety" on their admission to conventional hospitalization.
    TEMOINS patients

    TEMOINS patients with conventional follow-up who will not benefit from the medical hypnosis technique.

    Outcome Measures

    Primary Outcome Measures

    1. STAI questionnaire dimension STAI completed at discharge. [At discharge, an average 10 days]

      STAI-ETAT

    Secondary Outcome Measures

    1. The STAI ETAT (the current emotional state) questionnaire [at baseline and at discharge, an average 10 days]

      State Trait Anxiety Inventory Etat - Trait (40 questions - each item has a score from 1 to 4 (4 being the highest level of anxiety))

    2. The STAI-TRAIT (the usual emotional state ) questionnaire [at baseline and at discharge, an average 10 days]

      State-Trait Anxiety Inventory (STAI-TRAIT) SCORE: 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety

    3. patient opinion questionnaire [At discharge, an average 10 days]

    4. The difference in STAI STATUS score between the questionnaire completed post-hypnotic treatment and the questionnaire at admission [At discharge, an average 10 days]

    5. The ordinal severity scale correlated with the STAI ETAT questionnaire score; [At discharge, an average 10 days]

    6. Self-rated stress scale correlated with the STAI ETAT questionnaire score. [At discharge, an average 10 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients hospitalised in the internal medicine department of the Lille University Hospital

    • Age>= 18 years

    • Patients having expressed their non opposition

    Exclusion Criteria:

    • Not covered by the social security system

    • Person unable to receive informed information

    • Persons deprived of liberty

    • Persons under legal protection (guardianship / curatorship)

    • Psychotic and/or dementia disorders

    • Pregnant and breastfeeding women

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Mereym-Maud FAHRAT, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05760014
    Other Study ID Numbers:
    • 2022_0670
    • 2022-A02406-37
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 8, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    hypnosis
    perceived stress
    place of safety
    case control study

    Study Results

    No Results Posted as of Mar 8, 2023