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Набор по приглашению NCT05887856

Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial

Без фазы С лечением Patient Satisfaction Preoperative Anxiety Anxiety

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: comprehensive educational program for reduction of Pre-Operative Anxiety.
Кому может быть актуально
Состояния в реестре: Patient Satisfaction, Preoperative Anxiety, Anxiety. Базовые параметры: 18 лет — 70 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
Пакистан
Следующий шаг
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Обзор

This study aims to find out that if a specially designed educational program can help in reduction of pre-operative anxiety in breast cancer patients undergoing surgery as a part of their treatment.

Подробное описание

Anxiety can be defined as an unpleasant subjective experience associated with the perception of real threat; therefore, it is a common symptom in connection with cancer. Breast Cancer patients undergo surgery at some stage of their treatment, Surgery details can be overwhelming and might lead to low retention of information and greater levels of anxiety which is the most prevalent psychological symptoms perceived by cancer patients.

Studies have shown women with a diagnosis of cancer correlate with higher levels of preoperative anxiety. Increased anxiety elicits physiologic stress responses that may impede healing and alter responses to postoperative pain.It can also lead to delayed recovery, prolonged hospital stay and increased need of postoperative pain medications.

Pre-Operative Anxiety may also cause delayed recovery from Anesthesia and can also compromise the effectiveness of anesthesia .Furthermore, it can lead to other post-operative complications such as nausea, vomiting, and delayed wound healing. Various Pharmacological and non-pharmacological methods have been used for reduction of pre-operative anxiety and one such non-pharmacological method is educating the patients about the experience of surgery pre-operatively which we aim to study in our population.

Вмешательства

  • Другое comprehensive educational program for reduction of Pre-Operative Anxiety
    BSEP 1 makes use of modern media and aims to educate patients and their carers through educational videos comprising of various aspect of surgical treatment. 1. Introduction to surgery by consultant surgeon, Patient to receive video of their own surgeon. 2. Introduction to Anesthesia. 3. What are different type of breast surgeries in cancer patients (General Video) 4. Specific video pertaining to the type of surgery patient is undergoing (Mastectomy, Breast Conserving Surgery, Breast Re Constru

Первичные конечные точки

  • Patient Pre-Operative Anxiety [Срок оценки: 6 months]
Вторичные конечные точки (1)
  • Patient Satisfaction. [Срок оценки: 6 Months]

Критерии участия

Критерии включения

  • 18 to 70 years of age.
  • Known cases of Breast Cancer.
  • Undergoing Breast Surgery as a part of treatment.
  • Availability of Personal smart phone at home.
  • Written informed Consent given for participation in trial.
  • Females.

Критерии исключения

  • Less than 18 years or more than 70 years of age.
  • Stage IV patients undergoing palliative breast surgery.
  • Patient having chronic pain.
  • Un-availability of smart phone.
  • Patients with known psychiatric/depression disorders.
  • Previous history of another treated carcinoma.
  • Patients with re-current breast carcinoma.
  • Male Patients are excluded from study.

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
Тройное слепое
Основная цель
Профилактика

Центры проведения

Пакистан · 1 центр
  • Shaukat Khanum memorial cancer hospital and research centre — Lahore

Идентификаторы

NCT: NCT05887856 · IRB-22-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗