The Development and Evaluation of Sleep Intervention for Perinatal Family (NCT06487650) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Development and Evaluation of Sleep Intervention for Perinatal Family
600 participantsStarted 2025-12
Plain-language summary
Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health.
Objectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes.
Methods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics.
Anticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. First-time mothers and their partners aged 20 and older;
✓. Currently 30 weeks gestation or more, singleton;
✓. insomnia severity index score greater than 10;
✓. living with a husband or partner;
✓. Both women and their partners are willing to participate in and adhere to the research protocol;
✓. be able to read and speak the Mandarin language
Exclusion criteria
✕. sleep disorders, depression or anxiety disorders;
✕. medical diseases with abnormal heart rate variability, or arrhythmia;
✕. taking medicines that may affect the autonomic nervous system or
✕. night shift workers;
✕. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
What they're measuring
1
Insomnia Severity Index
Timeframe: baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum