Sömnhälsovård under graviditet: En randomiserad kontrollerad 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Taipei
-
Taipei, Taipei, Taiwan, 10051
- National Taiwan University Hospital
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Inget ingripande: Control
Women in the control group will receive standard obstetric care. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Daily 24-hour Sleep Duration
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sleep Efficiency
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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).
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Shao-Yu Tsai, National Taiwan University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 202209036RINC
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