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Hypnosis: a Path to Appeasement (HYCVA)

Primary Purpose

Hematologic Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anxiety questionnaire
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hematologic Cancer focused on measuring hypnosis, Diffuse large cell B-cell lymphoma, follicular lymphoma, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients over 18 years old, fluent in French. Patients starting hypnotherapy for anxiety disorders. Anxiety score on the HADS scale (Hospital Anxiety and Depression Scale) greater than or equal to 8/21 Patients with diffuse large cell B-cell lymphoma or follicular lymphoma, whatever the stage of the disease. Diagnosis announcement less than 2 months old Exclusion Criteria: Persons deprived of their liberty by a judicial or administrative decision Adults subject to a legal protection measure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Anxiety scores

    Arm Description

    Outcomes

    Primary Outcome Measures

    Evolution of anxiety
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.

    Secondary Outcome Measures

    Evolution of anxiety before hypnotherapy and after 3 months of follow-up in hypnotherapy
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Evolution of anxiety between D0 and M3 according to the type of lymphoma
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions for two subgroups : follicular lymphoma and diffuse large b-cell lymphoma. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Evolution of anxiety between D0 and W6 according to the type of lymphoma
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions for two subgroups : follicular lymphoma and diffuse large b-cell lymphoma. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Evolution of anxiety between D0 and W6 according to the gender of the patient
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions for two subgroups : man and woman. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Evolution of anxiety between D0 and M3 according to the gender of the patient
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions for two subgroups : man and woman. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Evolution of anxiety between D0 and W6 according to age category
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions for two subgroups : under 60 years old ans over 60 years old. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Evolution of anxiety between D0 and M3 according to age category
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions for two subgroups : under 60 years old ans over 60 years old. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.

    Full Information

    First Posted
    July 3, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Hospices Civils de Lyon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05942885
    Brief Title
    Hypnosis: a Path to Appeasement
    Acronym
    HYCVA
    Official Title
    Hypnosis: a Path to Appeasement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospices Civils de Lyon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hypnosis is a technique allowing the patient to focus his mental attention on a thought or a sensation, with the aim of reducing or modulating the intensity of a negative feeling or an ordeal encountered during the course of treatment. This tool can be used when patients are faced with chronic disorders (pain, anxiety, ...) or iatrogenic effects (nausea, asthenia, ...). The patient is referred to hypnosis care by the doctor, psychologist or paramedics who follow him, when they detect a need. Several scientific studies have shown the effectiveness of hypnosis in improving the quality of life of patients with breast cancer and in reducing pain during invasive procedures. On the other hand, in hematology, no research has measured the evolution of anxiety, over time, in patients receiving hypnotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematologic Cancer
    Keywords
    hypnosis, Diffuse large cell B-cell lymphoma, follicular lymphoma, anxiety

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anxiety scores
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    anxiety questionnaire
    Intervention Description
    Patient undergoing hypnosis session will have their anxiety measured just before the third session of hypnosis and after during a telephonic consultation. The result will be compared to the anxiety level before the first hypnosis session
    Primary Outcome Measure Information:
    Title
    Evolution of anxiety
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Week 6 after 2 hypnosis sessions
    Secondary Outcome Measure Information:
    Title
    Evolution of anxiety before hypnotherapy and after 3 months of follow-up in hypnotherapy
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Month 3 after 3 hypnosis sessions
    Title
    Evolution of anxiety between D0 and M3 according to the type of lymphoma
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions for two subgroups : follicular lymphoma and diffuse large b-cell lymphoma. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Month 3 after 3 hypnosis sessions
    Title
    Evolution of anxiety between D0 and W6 according to the type of lymphoma
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions for two subgroups : follicular lymphoma and diffuse large b-cell lymphoma. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Week 6 after 2 hypnosis sessions
    Title
    Evolution of anxiety between D0 and W6 according to the gender of the patient
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions for two subgroups : man and woman. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Week 6 after 2 hypnosis sessions
    Title
    Evolution of anxiety between D0 and M3 according to the gender of the patient
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions for two subgroups : man and woman. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Month 3 after 3 hypnosis sessions
    Title
    Evolution of anxiety between D0 and W6 according to age category
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 2 hypnosis sessions for two subgroups : under 60 years old ans over 60 years old. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Week 6 after 2 hypnosis sessions
    Title
    Evolution of anxiety between D0 and M3 according to age category
    Description
    Difference in anxiety measured before starting hypnotherapy care and after 3 hypnosis sessions for two subgroups : under 60 years old ans over 60 years old. It will be measured by the Hospital Anxiety and Depression Scale. This scale gives a score according to the level of anxiety ranging from 0 to 21. The higher the score, the more the patient is anxious.
    Time Frame
    Month 3 after 3 hypnosis sessions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years old, fluent in French. Patients starting hypnotherapy for anxiety disorders. Anxiety score on the HADS scale (Hospital Anxiety and Depression Scale) greater than or equal to 8/21 Patients with diffuse large cell B-cell lymphoma or follicular lymphoma, whatever the stage of the disease. Diagnosis announcement less than 2 months old Exclusion Criteria: Persons deprived of their liberty by a judicial or administrative decision Adults subject to a legal protection measure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas BERT
    Phone
    04.78.86.43.45
    Email
    thomas.bert01@chu-lyon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas BERT
    Organizational Affiliation
    Hospices Civils de Lyon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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