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NCT Number: NCT04513444

Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location status: Recruiting

Location contact

Anne DUCASSOU

CONTACT

[email protected]

05 31 15 54 15

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years at the time of enrollment into the study.
  • Patient with localized or metastatic solid malignant tumor.
  • 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).
  • Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
  • Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
  • ECOG patient ≤ 2.
  • Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
  • Patient affiliated to a Social Health Insurance in France.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

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)

    Time frame: 2 months for each patient

    Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).

Secondary outcomes

  1. Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious")

    Time frame: 2 months for each patient

  2. Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30).

    Time frame: 2 months for each patient

    Changes in quality of life from baseline will be assessed in the classroom according to the recommendations of the literature (Osoba, JCO).

Study contacts

Contact information is provided by the study sponsor or research team.

Anne DUCASSOU

CONTACT

[email protected]

05 31 15 54 15

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study title

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

Acronym: HYPNOMUSE

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2020
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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