Sleep Improvement Therapy Affects Pregnancy Outcomes in Chinese Singletons and Twins by Improving Sleep Quality

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-11-01

Brief Summary

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During pregnancy, the physical and psychological changes of pregnant women, hyperemesis gravidarum, uterine compression, frequent urination, hip or pelvic pain, back pain, leg cramps, gastroesophageal reflux, changes in mental state, and even changes in lifestyle, habits and tastes may affect the sleep of pregnant women. Due to the coexistence of physiological, psychological, social and other complex factors during pregnancy, the incidence of sleep disorders in pregnant women is relatively high, up to 50%, and shows an increasing trend with the increase of gestational week. Not only seriously affect the quality of life of pregnant women, but also may lead to a variety of pregnancy complications, and even lead to adverse pregnancy outcomes. Therefore, early identification, timely diagnosis and treatment of sleep disorders during pregnancy are important measures to improve or even reverse adverse pregnancy outcomes. Although sleep disorders are more common and seriously harmful during pregnancy, people lack of understanding and attention to such diseases, and often regard them as normal clinical manifestations of pregnancy and neglect diagnosis and treatment.

Studies have shown that maternal sleep disorders are associated with hypertensive disorders during pregnancy, preterm birth, and gestational diabetes. Current research objects mainly focus on single pregnancy, twin related research is less.

The purpose of this study is to explore the perinatal sleep health of pregnant women with twin pregnancies, reduce the complications of pregnant women with twin pregnancies and improve the pregnancy outcomes of mothers and infants by improving sleep quality.

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Detailed Description

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Conditions

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Gestational Diabetes Hypertension in Pregnancy Preterm Labor NICU Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sleep improvement Therapy group(CBT-I)

Group Type EXPERIMENTAL

Sleep restriction

Intervention Type BEHAVIORAL

Go to bed before 23pm

Stimulation control

Intervention Type BEHAVIORAL

Avoid drugs, alcohol, caffeine, and nicotine

Cognitive therapy

Intervention Type BEHAVIORAL

Listen to 30 minutes of soothing music every night for 8 weeks

Control group (TAU)

Group Type PLACEBO_COMPARATOR

Sleep principles discussion

Intervention Type BEHAVIORAL

The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction

Interventions

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Sleep restriction

Go to bed before 23pm

Intervention Type BEHAVIORAL

Stimulation control

Avoid drugs, alcohol, caffeine, and nicotine

Intervention Type BEHAVIORAL

Cognitive therapy

Listen to 30 minutes of soothing music every night for 8 weeks

Intervention Type BEHAVIORAL

Sleep principles discussion

The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Jun Wei

Department of Gynecology and Obstetrics

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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