Sleep Health Care in Pregnancy: A Randomized Controlled Trial

NCT ID: NCT05694780

Last Updated: 2025-05-21

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep intervention

Intervention Type BEHAVIORAL

Standard obstetric care plus the sleep intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Control

Women in the control group will receive standard obstetric care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep intervention

Standard obstetric care plus the sleep intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* During the first trimester of pregnancy
* Singleton pregnancies

Exclusion Criteria

* Women have pregnancy-related complications
* Women have diagnosed a psychiatric or sleep disorder
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shao-Yu Tsai

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shao-Yu Tsai

Role: CONTACT

0905676805

Jia-Chun Huang

Role: CONTACT

(02)3366-7178

Facility Contacts

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Shao-Yu Tsai

Role: primary

Other Identifiers

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202209036RINC

Identifier Type: -

Identifier Source: org_study_id

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