Trials / Not Yet Recruiting
Not Yet RecruitingNCT06487650
The Development and Evaluation of Sleep Intervention for Perinatal Family
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Taipei Medical University · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Accepted
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.
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 will be collected. Infant sleep quality, infant feeding, and infant health outcomes will also be assessed. Data will be analyzed using descriptive and inferential statistics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2024-07-05
- Last updated
- 2025-01-14
Source: ClinicalTrials.gov record NCT06487650. Inclusion in this directory is not an endorsement.