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Идёт набор NCT07698925

Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

Без фазы С лечением Polycystic Ovarian Syndrome (PCOS) Pittsburg Sleep Quality Index Fatigue Severity Scale Insomnia Severity Index

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: Diaphragmatic breathing exercises, Lifestyle modification advices.
Кому может быть актуально
Состояния в реестре: Polycystic Ovarian Syndrome (PCOS), Pittsburg Sleep Quality Index, Fatigue Severity Scale, Insomnia Severity Index. Базовые параметры: 25 лет — 35 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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Официальное название

Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome

Обзор

Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder in females in reproductive age and not completely understood. Women with PCOS appear to have an increased frequency of sleep problems. Diaphragmatic Breathing (DB) exercises has positive effects on improving sleep quality. The purpose of this study will evaluate the effect of diaphragmatic breathing exercises on improving sleep quality in polycystic ovarian syndrome women.

Подробное описание

Polycystic ovary syndrome (PCOS) is one of the most prevalent metabolic and reproductive disorders impacting women of reproductive age. Difficulty falling asleep and maintaining sleep has been reported among women with PCOS. Taken together, these data suggest that women with PCOS are at an increased risk for sleep disturbances, obesity and depression are associated with the increased risk. Pharmacotherapy is only recommended for the short term. This is particularly pertinent for women with PCOS whose insomnia and other sleep disturbances are unlikely to be short term and are related to underlying factors that need to be addressed directly. So, there is an urgent need to a safe method for PCOS women such as diaphragmatic breathing that need further more investigations which will be conducted in this study.

Вмешательства

  • Другое Diaphragmatic breathing exercises
    Its course is 3 times per week, 6 minutes twice a day, for 8 weeks. When it's the first time to learn how to perform the diaphragmatic breathing technique, it's easier to follow the instructions lying down in supine position with a pillow under head. The patient will be asked to place one hand on her abdomen, just below her ribcage, and the other hand on the middle of her chest to become aware of her diaphragm's position and function during breathing. She will be told to breathe slowly and deepl
  • Другое Lifestyle modification advices
    Avoid caffeine, smoking, alcohol, napping; thirsty or hungry Regular exercising, sleep timing, relax techniques; Reduce noise, Ensure bedroom clean, no TV, mobile in bed, snack near bed, warm bath pre sleep, wear sleep cloths, most relaxed position for sleep.

Первичные конечные точки

  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.]
Вторичные конечные точки (2)
  • Insomnia Severity Index (ISI) [Срок оценки: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.]
  • Fatigue Assessment Scale (FAS) [Срок оценки: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.]

Критерии участия

Критерии включения

  • Women aged from 25-35 years old, Diagnosed with PCOS by gynecologist, diagnosis of PCOS will be based on the 2003 Rotterdam criteria.
  • They have a Pittsburgh sleep quality index (PSQI) score greater than 5.
  • Not participating in any physical exercise for the previous 3 months.
  • They have an insomnia severity index score greater than 15.
  • They have a fatigue severity scale score greater than 36.
  • Ability to use internet and phone services

Критерии исключения

  • • Women with autoimmune diseases and cancer.
  • Women with neurological, mental, cardiopulmonary and musculoskeletal disorders.
  • Pregnant or lactating women.
  • Women who showed regular adherence to sleeping pills, antidepressants and hormonal replacement agents.
  • Inability to perform diaphragmatic breathing due to physical limitations.
  • Women who participate or receive any interventions that could affect their sleep

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Cairo University; Faculty of Physical Therapy — Cairo

Идентификаторы

NCT: NCT07698925 · P.T.REC/012/005971

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗