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NOT YET RECRUITING
NCT06487650
NA

The Development and Evaluation of Sleep Intervention for Perinatal Family

Sponsor: Taipei Medical University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-12

Completion Date

2026-09

Last Updated

2025-01-14

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

sleep intervention

At the beginning of the intervention, participants will have an orientation and overview of the program. Then, participants will follow the curriculum of modules, and professional feedback to complete the intervention.

BEHAVIORAL

Control group

Participants in control group will follow standardized usual care and a perinatal health booklet