Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Pregnancy Related
• Interventions: Behavioral: Sleep intervention

• Registration Number: NCT05694780
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• During the first trimester of pregnancy
• Singleton pregnancies

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Exclusion Criteria

• Women have pregnancy-related complications
• Women have diagnosed a psychiatric or sleep disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Sleep intervention	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.

Primary Outcome Measures

Name	Time	Method
Sleep by actigraphy	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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan