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Набира участници Фаза 2 NCT04513444

Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Solid Tumor

Спонсор: Institut Claudius Regaud

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: 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. Exclusion Criteria: 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).
Интервенции
Relaxation with music listening and medical hypnosis during radiotherapy treatment:
OTHER
Relaxation with music listening during radiotherapy treatment:
OTHER
Места на провеждане 1
Франция (1)
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
07.12.2020
Крайна дата
01.08.2027
Регистрационен номер
NCT04513444
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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