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Набор скоро начнётся NCT07032883

Benson Relaxation Technique Effectiveness on Pain and Quality of Life Post Reconstructive Mammoplasty

Без фазы С лечением Breast Cancer

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: Benson relaxation technique, Routine physiotherapy program, Medications.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: 25 лет — 50 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
Египет
Следующий шаг
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Обзор

The purpose of this study is to evaluate effectiveness of benson relaxation technique on pain and quality of life post mammoplasty.

Подробное описание

Pain post reconstructive mammoplasty is common and has an impact on psychosocial aspects, anxiety, sleep disorders and activities of daily living(ADL),as a result patients suffer from impairment in quality of life.

To manage pain pharmaceutical and non-pharmaceutical interventions could be used.

Benson relaxation is a deep breathing relaxation therapy that has been developed by involving a person's belief factor. It works by shifting the focus of pain so that the body becomes relaxed, this can increase endogenous analgesics and be strengthened again by reciting spiritual sentences that provide calm.

Benson relaxation technique has a major effect on reducing anxiety, depression, and improving quality of life and psychological factors. Furthermore, this technique is easy to learn and no side effects have been reported.

Вмешательства

  • Другое Benson relaxation technique
    It will be performed every day, twice daily (in the morning and evening), for 4weeks, the Benson relaxation technique instruction included these steps. 1. Sit in a comfortable position. 2. Close their eyes. 3. Relax all their muscles beginning from the soles of the feet, moving forward up, and relax all parts of their body. (4 ) Breath through their nose, pay attention to the sound of their breathing, and say the word ''one'' quietly to themselves when the breath is out. (5) Continue for 20 m
  • Другое Routine physiotherapy program
    The participants will receive routine physical therapy program (gentle stretching, manual therapy, mobility and strengthening exercises and posture training) for 40 minutes , for 4 weeks.
  • Препарат Medications
    the participants will receive the following medications: 1. Antibiotic: Ancef 1 g intravenous (IV) ( cefazolin) intravenous post-surgery every 8 hours for 24 hours. If allergic to ampicillin /cephalosporins clindamycin IV 600\_900 mg every 8 hours for 24 hours. Then continue oral with keflex 1g tablets (cephalexin) twice daily for 7 days. 2. Anti-inflammatory: Adolor ( ketorolac) 15\_30 mg IV every 6 hours up to 5 days post-operation ( not exceed 120 mg/day) then followed by oral celecoxib

Первичные конечные точки

  • Assessment of pain severity [Срок оценки: 4 weeks]
  • Assessment of quality of life [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • Only female patients underwent reconstruction mammoplasty will participate in the study.
  • Female patients who stopped chemotherapy at least one month before participation in the study.
  • Female patients with chronic pain following cosmetic breast surgery.
  • All patients who will accept to participate in the study after one week from operation.

Критерии исключения

  • Patients have irritable bowel syndrome.
  • Patients have urinary incontinence.
  • Chronic diseases like multiple sclerosis, polyneuropathy , diabetes and fibromyalgia.
  • Patients have cognitive disorder.
  • Patients with chronic and severe back pain.
  • Sepsis with complications postoperative hemodynamics.
  • Patients take anti-psychotic drugs.
  • Patients take hypnotic drugs.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Mohamed Abd El-Monem Morad — Tanta

Идентификаторы

NCT: NCT07032883 · P.T.REC/012/005668

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗