Hypnosis: a Path to Appeasement (HYCVA)

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Cancer
• Intervention / Treatment: Other: anxiety questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Bert; Phone Number: 04.78.86.43.45; Email: thomas.bert01@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite
    • Lyon, Pierre-Bénite, France, 69495
      • Recruiting
      • Service MB1 - Hôpital Lyon Sud - HCL
      • Contact: Thomas Bert; Phone Number: 04.78.86.43.45; Email: thomas.bert01@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anxiety scores	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Thomas BERT, Hospices civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; hypnosis; follicular lymphoma; Diffuse large cell B-cell lymphoma
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Anxiety Disorders; Hematologic Neoplasms; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular
• Other Study ID Numbers: 69HCL23_0336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No