Sleep Health Care in Pregnancy: A Randomized Controlled Trial

National Taiwan University

Status: Enrolling

Conditions: Pregnancy Related

Treatments: Behavioral: Sleep intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05694780

202209036RINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Experimental

Experimental group

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.

Treatment:

Behavioral: Sleep intervention

Control

No Intervention group

Description:

Women in the control group will receive standard obstetric care.