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
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
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
NCT ID
NCT05942885
First Posted
July 3, 2023
Last Updated
September 26, 2023
Sponsor
Hospices Civils de Lyon
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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Hypnosis: a Path to Appeasement
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