Идёт набор NCT05027321

Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies

Без фазы С лечением Breast Neoplasm Female

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Preparation in Self-Hypnosis by anchoring, Conversational Hypnosis, Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis.
Кому может быть актуально: Состояния в реестре: Breast Neoplasm Female. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies: a Randomized Study

Обзор

The incidence of breast cancer and its mortality are reduced thanks in particular to early detection. Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act. Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination. Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management. However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.

Вмешательства

Поведенческое Preparation in Self-Hypnosis by anchoring
Preparation in Self-Hypnosis by anchoring just before examination
Поведенческое Conversational Hypnosis
Conversational Hypnosis during examination
Поведенческое Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination

Первичные конечные точки

change in anxiety score [Срок оценки: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days]

Вторичные конечные точки (8)

change in anxiety score [Срок оценки: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days]
change in pain score [Срок оценки: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days]
patient examination experience [Срок оценки: baseline (immediately after the intervention)]
staff examination experience [Срок оценки: baseline (immediately after the intervention)]
anxiety score [Срок оценки: baseline (pre-intervention)]
Amount of nesthetic administered to the patiet during the procedure [Срок оценки: baseline (immediately after the intervention)]
Examination duration [Срок оценки: baseline (immediately after the intervention)]
AE/SAE reporting [Срок оценки: baseline (during the intervention, immediatly after the intervetion) and at 8 days]

Критерии участия

Критерии включения

aged 18 or over,
referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy,
naive of any hypnosis,
having given free, informed and written consent,
being affiliated to a social security scheme or beneficiary of such scheme