Opieka zdrowotna nad snem w ciąży: randomizowana, kontrolowana próba (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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Taipei
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Taipei, Taipei, Tajwan, 10051
- National Taiwan University Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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. |
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Brak interwencji: Control
Women in the control group will receive standard obstetric care. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Daily 24-hour Sleep Duration
Ramy czasowe: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
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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).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sleep Efficiency
Ramy czasowe: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
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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).
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Sleep Onset Latency
Ramy czasowe: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
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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).
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Wake After Sleep Onset
Ramy czasowe: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
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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).
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Total Nighttime Sleep
Ramy czasowe: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
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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).
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Nap Duration
Ramy czasowe: First trimester (baseline, approximately Week 10 of gestation) and third trimester (study completion, approximately Week 31 of gestation).
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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).
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Pittsburgh Sleep Quality Index
Ramy czasowe: 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).
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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).
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Center for Epidemiologic Studies Depression (CES-D) Scale
Ramy czasowe: 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).
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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).
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Parents' Sleep Knowledge Inventory (PSKI)
Ramy czasowe: 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).
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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).
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Shao-Yu Tsai, National Taiwan University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 202209036RINC
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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