Soins de santé du sommeil pendant la grossesse : un essai contrôlé randomisé (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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taipei
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Taipei, Taipei, Taïwan, 10051
- National Taiwan University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Control
Women in the control group will receive standard obstetric care. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Daily 24-hour Sleep Duration
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sleep Efficiency
Délai: 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
Délai: 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
Délai: 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).
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Total Nighttime Sleep
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shao-Yu Tsai, National Taiwan University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 202209036RINC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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