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Clinical Trial NCT04513444 (HYPNOMUSE) for Solid Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy (HYPNOMUSE)

Recruiting
Clinical Trial NCT04513444 (HYPNOMUSE) is designed to study Supportive Care for Solid Tumor. It is a Phase 2 interventional trial that is recruiting, having started on 7 December 2020, with plans to enroll 45 participants. Led by Institut Claudius Regaud, it is expected to complete by 1 February 2026. The latest data from ClinicalTrials.gov was last updated on 4 April 2025.
Brief Summary
This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.

45 patients will be randomized into the following arms:

  • Arm A (standard): relaxation with music listening during radiotherapy treatment
  • Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment

For the study each patient will be followed during 2 months.

Official Title

Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Conditions
Solid Tumor
Other Study IDs
  • HYPNOMUSE
  • 20 GENE 07
NCT ID Number
NCT04513444
Start Date (Actual)
2020-12-07
Last Update Posted
2025-04-04
Completion Date (Estimated)
2026-02
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Solid Tumor
Radiotherapy
Hypnosis
Anxiety
Music listening
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherStandard arm (A): music listening therapy
Relaxation with Music Listening During Radiotherapy Treatment:
* Music listening (According to the patient's wishes), * Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.
ExperimentalExperimental arm (B): music listening and hypnosis therapy
Relaxation with Music Listening and Medical Hypnosis During Radiotherapy Treatment:
* Music listening (According to the patient's wishes), * Hypnosis sessions with the hypnotherapist during the 1st, 2nd and 3rd radiotherapy session, * Self-hypnosis during the 4th and 5th radiotherapy session, * Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)
Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).
2 months for each patient
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious")
2 months for each patient
Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30).
Changes in quality of life from baseline will be assessed in the classroom according to the recommendations of the literature (Osoba, JCO).
2 months for each patient
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age ≥ 18 years at the time of enrollment into the study.
  2. Patient with localized or metastatic solid malignant tumor.
  3. Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study).
  4. Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
  5. Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
  6. ECOG patient ≤ 2.
  7. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
  8. Patient affiliated to a Social Health Insurance in France.

  1. Patient doesn't understand the French language.
  2. Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
  3. Patient with hearing problems.
  4. Pregnant or breastfeeding women.
  5. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
  6. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Institut Claudius Regaud logoInstitut Claudius Regaud
Study Central Contact
Contact: Anne DUCASSOU, 05 31 15 54 15, [email protected]
1 Study Locations in 1 Countries
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, 31059, France
Anne DUCASSOU, Contact, 05 31 15 54 15, [email protected]
Recruiting