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Набор скоро начнётся NCT07355244

Self-Affirmation Intervention After Mastectomy

Без фазы С лечением Breast Neoplasms Mastectomy; Lymphedema Pain Depression

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: Positive Self-Affirmation Audio with Calming Background Sounds.
Кому может быть актуально
Состояния в реестре: Breast Neoplasms, Mastectomy; Lymphedema, Pain, Depression. 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
Список центров уточняется — проверьте первичный протокол.
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

The Effect of Self-Affirmation Skills on Pain, Depression, Anxiety, and Stress in Patients Undergoing Mastectomy: A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to evaluate the effect of a structured self-affirmation intervention on pain, depression, anxiety, and stress levels in patients undergoing mastectomy. The study will be conducted in two parallel groups, with the intervention group listening to an audio recording of positive self-affirmation statements. Primary outcomes will be assessed using the Visual Analog Scale and the Depression Anxiety Stress Scale (DASS-21). The goal is to provide evidence-based strategies to reduce psychosocial burden after mastectomy.

Подробное описание

This randomized controlled trial is designed to evaluate the effect of a structured self-affirmation intervention on pain, depression, anxiety, and stress levels in patients undergoing mastectomy. Breast cancer is the most commonly diagnosed cancer among women worldwide, and mastectomy, a standard surgical treatment, often results in significant physical and psychosocial consequences. The loss of a breast, perceived as a symbolic part of femininity, can severely impact body image and self-esteem, leading to psychological distress symptoms such as depression, anxiety, and stress, as well as chronic pain. These adverse effects not only reduce quality of life but also negatively influence treatment adherence and long-term survival.

In this study, participants in the intervention group will listen to an audio recording containing positive self-affirmation statements accompanied by soothing background sounds such as birds chirping and flowing water. The recording, prepared by a certified practitioner, lasts approximately 5 minutes and 40 seconds. Patients will be instructed to listen to the recording at least once daily, with encouragement to listen more frequently if desired. The control group will receive standard care without any additional intervention. Primary outcomes will be assessed using the Visual Analog Scale (VAS) for pain and the Depression Anxiety Stress Scale (DASS-21) for psychological distress. The ultimate goal of this trial is to develop an evidence-based nursing and psychosocial support protocol that can be integrated into postoperative care to reduce psychosocial burden and improve well-being in mastectomy patients.

Вмешательства

  • Поведенческое Positive Self-Affirmation Audio with Calming Background Sounds
    Participants in the intervention arm will receive a behavioral intervention consisting of an audio recording of positive self-affirmation statements accompanied by calming background sounds (birds chirping and flowing water). The recording lasts approximately 5 minutes and 40 seconds and will be delivered via an MP3 player and headphones. Patients will be instructed to listen to the recording at least once daily during the postoperative period, with encouragement to listen more frequently if des

Первичные конечные точки

  • Pain intensity [Срок оценки: Baseline (preoperative, T0), postoperative day 1 (T1), postoperative day 3 (T2, before discharge), and day 10 follow-up (T3).]
  • Depression, Anxiety, and Stress (DASS-21 subscales) [Срок оценки: T0 (preoperative baseline), T1 (post-op day 1), T2 (post-op day 3, before discharge), T3 (post-op day 10 follow-up).]
Вторичные конечные точки (1)
  • Intervention adherence (daily listening frequency) [Срок оценки: From T0 training through T3 (daily tracking until day 10 post-op).]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Female patients who have undergone mastectomy surgery
  • Able to speak and understand Turkish
  • Provides informed consent and agrees to participate voluntarily

Критерии исключения

  • Diagnosed psychiatric disorder
  • Hearing impairment that prevents listening to the audio intervention

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07355244 · 222391

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗