Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Sleep health promotion, Urologic health promotion, Pelvic floor muscle training.
- Кому может быть актуально
- Состояния в реестре: Conservative Management, Diabetes Mellitus, Health-related Quality of Life, Lower Urinary Tract Symptoms. Базовые параметры: 20 лет — 79 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
- Тайвань
- Следующий шаг
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Официальное название
Effects of Conservative Management Incorporating Urologic Health Promotion and Sleep Health Promotion on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
Обзор
Women with type 2 diabetes (n=90) experiencing ≥1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wards/units of the selected hospitals/clinics. Our study aims to examine the effects of conservative management incorporating urologic health promotion and sleep health promotion on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life. Women who agree to participate will be randomly assigned into the intervention group A, intervention group B, or comparison group. The intervention group A receives a 4-month conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion. The intervention group B receives a 4-month conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion. The comparison group receives information related to pelvic floor muscle training and urologic health promotion, and receives a brief conservative management related to sleep hygiene adjustments after the completion of data collection. Information related to intervention effects is obtained by a questionnaire, a wristwatch-like actigraphy, and physical activity/diet/voiding/sleep logs from all participants at 4 data collection points: baseline, and 2-, 4-, 6-month follow-ups. Our study hypothesis is that the intervention effects on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life in the intervention group A or B are superior to the changes revealed in the comparison group.
Подробное описание
Women with type 2 diabetes (n=90) experiencing ≥1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wards/units of the selected hospitals/clinics. Our study aims to examine the effects of conservative management incorporating urologic health promotion and sleep health promotion on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life. Women who agree to participate will be randomly assigned into the intervention group A, intervention group B, or comparison group. The intervention group A receives a 4-month conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion. The intervention group B receives a 4-month conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion. The comparison group receives information related to pelvic floor muscle training and urologic health promotion, and receives a brief conservative management related to sleep hygiene adjustments after the completion of data collection. Information related to intervention effects is obtained by a questionnaire, a wristwatch-like actigraphy, and physical activity/diet/voiding/sleep logs from all participants at 4 data collection points: baseline, and 2-, 4-, 6-month follow-ups. Our study hypothesis is that the intervention effects on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life in the intervention group A or B are superior to the changes revealed in the comparison group. The effects of the provided intervention on storage lower urinary tract symptoms, sleep quality, urologic health self-management behaviors, and health-related quality of life will be examined by Generalized Estimating Equations procedures with the estimations of effect sizes. Results of Chi-squared tests and descriptive statistics will also be used to present the intervention effects.
Вмешательства
- Поведенческое Sleep health promotion
We will provide sleep hygiene related adjustments in the intervention group A; and brief behavioral treatment for insomnia (BBTI) in the intervention group B. - Поведенческое Urologic health promotion
We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group). - Поведенческое Pelvic floor muscle training
We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).
Первичные конечные точки
- Lower urinary tract symptoms [Срок оценки: Baseline]
- Lower urinary tract symptoms [Срок оценки: The 2-month follow-up.]
- Lower urinary tract symptoms [Срок оценки: The 4-month follow-up.]
- Lower urinary tract symptoms [Срок оценки: The 6-month follow-up.]
- Sleep Quality [Срок оценки: Baseline.]
- Sleep Quality [Срок оценки: The 2-month follow-up.]
- Sleep Quality [Срок оценки: The 4-month follow-up.]
- Sleep Quality [Срок оценки: The 6-month follow-up.]
- Total nighttime sleep [Срок оценки: Baseline.]
- Total nighttime sleep [Срок оценки: The 2-month follow-up.]
Вторичные конечные точки (8)
- Health-related quality of life [Срок оценки: Baseline.]
- Health-related quality of life [Срок оценки: The 2-month follow-up.]
- Health-related quality of life [Срок оценки: The 4-month follow-up.]
- Health-related quality of life [Срок оценки: The 6-month follow-up.]
- Self-management of urologic health [Срок оценки: Baseline.]
- Self-management of urologic health [Срок оценки: The 2-month follow-up.]
- Self-management of urologic health [Срок оценки: The 4-month follow-up.]
- Self-management of urologic health [Срок оценки: The 6-month follow-up.]
Критерии участия
Критерии включения
- Women
- Age 50-79 years
- Clinical diagnosis of diabetes >3 months
- Experiencing ≥1 storage lower urinary tract symptoms in the past 1 month
- Experiencing poor sleep health in the past 1 month
- Intact cognition and communication abilities
Критерии исключения
- Receiving urologic problems related treatments in the past 3 months
- Receiving sleep problems related treatments in the past 3 months
- Receiving mental problems related treatments in the past 3 months
- Having a history of spinal surgery, cardiovascular, renal, or nervous system diseases
- Having severe mental illness
- Having physical impairments
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
Тайвань · 1 центр
- Cardinal Tien Hospital — New Taipei City
Идентификаторы
NCT: NCT05869734 · 11131006