NCT05942885

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Oct 2023Jul 2026

First Submitted

Initial submission to the registry

July 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

July 3, 2023

Last Update Submit

September 5, 2025

Conditions

Hematologic Cancer

Keywords

hypnosisDiffuse large cell B-cell lymphomafollicular lymphomaanxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Evolution of anxiety before hypnotherapy and after 3 months of follow-up in hypnotherapy

    Month 3 after 3 hypnosis sessions

  • Evolution of anxiety between D0 and M3 according to the type of lymphoma

    Month 3 after 3 hypnosis sessions

  • Evolution of anxiety between D0 and W6 according to the type of lymphoma

    Week 6 after 2 hypnosis sessions

  • Evolution of anxiety between D0 and W6 according to the gender of the patient

    Week 6 after 2 hypnosis sessions

  • Evolution of anxiety between D0 and M3 according to the gender of the patient

    Month 3 after 3 hypnosis sessions

  • +2 more secondary outcomes

Study Arms (1)

Anxiety scores

EXPERIMENTAL
Other: anxiety questionnaire

Interventions

anxiety questionnaireOTHER

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

Anxiety scores

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Persons deprived of their liberty by a judicial or administrative decision
  • Adults subject to a legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service MB1 - Hôpital Lyon Sud - HCL

Lyon, Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsLymphoma, Large B-Cell, DiffuseLymphoma, FollicularAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMental Disorders

Study Officials

  • Thomas BERT

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas BERT

CONTACT

04.78.86.43.45thomas.bert01@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 12, 2023

Study Start

October 30, 2023

Primary Completion

April 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)