Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: December 31, 2025
Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.
- Behavioral: Sleep intervention
- Standard obstetric care plus the sleep intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.
Arms, Groups and Cohorts
- Experimental: Experimental
- Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.
- No Intervention: Control
- Women in the control group will receive standard obstetric care.
Clinical Trial Outcome Measures
- Sleep by actigraphy
- Time Frame: Through study completion, an average of 16 weeks
- Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist
Participating in This Clinical Trial
- During the first trimester of pregnancy – Singleton pregnancies Exclusion Criteria:
- Women have pregnancy-related complications – Women have diagnosed a psychiatric or sleep disorder
Gender Eligibility: Female
Minimum Age: 20 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- National Taiwan University Hospital
- Provider of Information About this Clinical Study
- Overall Official(s)
- Shao-Yu Tsai, Principal Investigator, National Taiwan University
- Overall Contact(s)
- Shao-Yu Tsai, 0905676805, firstname.lastname@example.org
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