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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05942885
Other study ID # 69HCL23_0336
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date July 30, 2025

Study information

Verified date November 2023
Source Hospices Civils de Lyon
Contact Thomas BERT
Phone 04.78.86.43.45
Email thomas.bert01@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
anxiety questionnaire
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

Locations

Country Name City State
France Service MB1 - Hôpital Lyon Sud - HCL Lyon Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 6 after 2 hypnosis sessions
Secondary 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. Month 3 after 3 hypnosis sessions
Secondary 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. Month 3 after 3 hypnosis sessions
Secondary 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. Week 6 after 2 hypnosis sessions
Secondary 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. Week 6 after 2 hypnosis sessions
Secondary 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. Month 3 after 3 hypnosis sessions
Secondary 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. Week 6 after 2 hypnosis sessions
Secondary 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. Month 3 after 3 hypnosis sessions
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