Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

NCT04513444 | Recruiting Phase 2

• 1 other identifier: 20 GENE 07
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Solid Tumor; Radiotherapy; Hypnosis; Anxiety; Music listening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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).

  2 months for each patient

Study Arms (2)

Standard arm (A): music listening therapy

OTHER

Other: Relaxation with music listening during radiotherapy treatment:

Experimental arm (B): music listening and hypnosis therapy

EXPERIMENTAL

Other: Relaxation with music listening and medical hypnosis during radiotherapy treatment:

Interventions

Relaxation with music listening and medical hypnosis during radiotherapy treatment: OTHER

* 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.

Experimental arm (B): music listening and hypnosis therapy

Relaxation with music listening during radiotherapy treatment: OTHER

* 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.

Standard arm (A): music listening therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of enrollment into the study.
• Patient with localized or metastatic solid malignant tumor.
• Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
• ECOG patient ≤ 2.
• Patient affiliated to a Social Health Insurance in France.

You may not qualify if:

• Patient doesn't understand the French language.
• Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
• Patient with hearing problems.
• Pregnant or breastfeeding women.
• Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
• Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Anne DUCASSOU

CONTACT

05 31 15 54 15; ducassou.anne@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: December 7, 2020
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

FR (1)