The Development and Evaluation of Sleep Intervention for Perinatal Family
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Medical University
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- sleep intervention
- Control group
Treatment groups
600 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov