Уход за сном во время беременности: рандомизированное контролируемое исследование (STEP)
Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Women in the intervention group will receive standard obstetric care plus the STEP intervention which is an 8-week program based on sleep hygiene education and cognitive-behavioral training.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Taipei
-
Taipei, Taipei, Тайвань, 10051
- National Taiwan University Hospital
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- During the first trimester of pregnancy
- Singleton pregnancies
Exclusion Criteria:
- Women have pregnancy-related complications
- Women have diagnosed a psychiatric or sleep disorder
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental
Women in the intervention group will receive standard obstetric care plus the STEP intervention which is an 8-week program based on sleep hygiene education and cognitive-behavioral training. |
Standard obstetric care plus the sleep intervention which is an 8-week program based on sleep hygiene education and cognitive-behavioral training. |
|
Без вмешательства: Control
Women in the control group will receive standard obstetric care. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Daily 24-hour Sleep Duration
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
Daily 24-hour sleep duration is defined as total nighttime sleep plus nap duration, averaged across 7 consecutive days of actigraphy. |
First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Sleep Efficiency
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
Sleep efficiency, a key indicator of sleep quality, is calculated as total nighttime sleep divided by time in bed × 100%. Data were averaged across 7 consecutive days of actigraphy. |
First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
|
Sleep Onset Latency
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
Sleep onset latency is defined as the duration (minutes) from diary-reported bedtime to actigraphy-derived sleep onset. Data were averaged across 7 consecutive days of actigraphy. |
First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
|
Wake After Sleep Onset
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
Wake after sleep onset (WASO) is defined as the duration (minutes) scored as wake between sleep onset and final awakening. Data were averaged across 7 consecutive days of actigraphy. |
First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
|
Total Nighttime Sleep
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
Total nighttime sleep is defined as the total duration (minutes) scored as sleep within the nocturnal rest interval. Data were averaged across 7 consecutive days of actigraphy. |
First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
|
Nap Duration
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
Nap duration is defined as the total minutes scored as sleep outside the nocturnal rest interval. Data were averaged across 7 consecutive days of actigraphy. |
First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
|
|
Pittsburgh Sleep Quality Index
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation), second trimester (approximately Week 20 of gestation), and third trimester (study completion, approximately Week 31 of gestation).
|
The 19-item Pittsburgh Sleep Quality Index (PSQI) evaluates sleep patterns over the past month. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
First trimester (baseline, approximately Week 10 of gestation), second trimester (approximately Week 20 of gestation), and third trimester (study completion, approximately Week 31 of gestation).
|
|
Center for Epidemiologic Studies Depression (CES-D) Scale
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation), second trimester (approximately Week 20 of gestation), and third trimester (study completion, approximately Week 31 of gestation).
|
The 20-item Center for Epidemiologic Studies Depression Scale (CES-D) assesses the frequency of depressive symptoms experienced over the past week. Total scores range from 0 to 60, where higher scores indicate greater symptom severity; a score of 16 or higher is the standard clinical cutoff indicative of a risk for depression. |
First trimester (baseline, approximately Week 10 of gestation), second trimester (approximately Week 20 of gestation), and third trimester (study completion, approximately Week 31 of gestation).
|
|
Parents' Sleep Knowledge Inventory (PSKI)
Временное ограничение: First trimester (baseline, approximately Week 10 of gestation), second trimester (approximately Week 20 of gestation), and third trimester (study completion, approximately Week 31 of gestation).
|
The 25-item infant subscale of the Parents' Sleep Knowledge Inventory (PSKI) assesses parental knowledge of infant sleep patterns and sleep-related problems, with a higher percentage of correct responses indicating better knowledge. |
First trimester (baseline, approximately Week 10 of gestation), second trimester (approximately Week 20 of gestation), and third trimester (study completion, approximately Week 31 of gestation).
|
Соавторы и исследователи
Следователи
- Главный следователь: Shao-Yu Tsai, National Taiwan University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 202209036RINC
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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