Status:
NOT_YET_RECRUITING
The Development and Evaluation of Sleep Intervention for Perinatal Family
Lead Sponsor:
Taipei Medical University
Conditions:
Sleep
Psychological Distress
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 interventio...
Detailed Description
The primary outcome is the severity of insomnia symptoms. The secondary outcomes of parents' sleep quality, objective sleep indicators, symptoms of depression and anxiety, and heart rate variability w...
Eligibility Criteria
Inclusion
- 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
- 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;
- infants with fetal deformity, or neonatal complications;
- no access to Internet resources
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06487650
Start Date
December 1 2025
End Date
September 1 2026
Last Update
January 14 2025
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