Slaapgezondheidszorg tijdens de zwangerschap: een gerandomiseerde gecontroleerde studie (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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Taipei
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Taipei, Taipei, Taiwan, 10051
- National Taiwan University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Geen tussenkomst: Control
Women in the control group will receive standard obstetric care. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Daily 24-hour Sleep Duration
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sleep Efficiency
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Shao-Yu Tsai, National Taiwan University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 202209036RINC
Plan Individuele Deelnemersgegevens (IPD)
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