Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy (NCT04513444) | Clinical Trial Compass
RecruitingPhase 2
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
France45 participantsStarted 2020-12-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
✕
What they're measuring
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)
. 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).