The Development and Evaluation of Sleep Intervention for Perinatal Family
NCT ID: NCT06487650
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
600 participants
INTERVENTIONAL
2025-12-31
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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sleep intervention
Participants in the intervention group will receive both the standardized usual care and the sleep intervention. The intervention consists of sleep education, health professional support, and counseling. The intervention will be delivered from pregnancy to postpartum for mothers and fathers.
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.
Control
Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care.
Control group
Participants in control group will follow standardized usual care and a perinatal health booklet
Interventions
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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.
Control group
Participants in control group will follow standardized usual care and a perinatal health booklet
Eligibility Criteria
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Inclusion Criteria
2. Currently 30 weeks gestation or more, singleton;
3. insomnia severity index score greater than 10;
4. living with a husband or partner;
5. Both women and their partners are willing to participate in and adhere to the research protocol;
6. be able to read and speak the Mandarin language
Exclusion Criteria
2. medical diseases with abnormal heart rate variability, or arrhythmia;
3. taking medicines that may affect the autonomic nervous system or
4. night shift workers;
5. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
6. infants with fetal deformity, or neonatal complications;
7. no access to Internet resources
20 Years
ALL
Yes
Sponsors
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Taipei Medical University
OTHER
Responsible Party
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Principal Investigators
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Shu-Yu Kuo, Phd
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University
Central Contacts
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Other Identifiers
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N202204079
Identifier Type: -
Identifier Source: org_study_id
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