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The Development and Evaluation of Sleep Intervention for Perinatal Family

NCT06487650 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-01-14

No results posted yet for this study

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.

Conditions

  • Sleep
  • Psychological Distress
  • Perinatal Problems

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

Sponsors & Collaborators

  • Taipei Medical University

    lead OTHER

Principal Investigators

  • Shu-Yu Kuo, Phd · Taipei Medical University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-09-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487650 on ClinicalTrials.gov