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Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial.

Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial. - Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055936
Enrollment
80
Registered
2024-10-24
Start date
2024-10-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Pregnant Women Diagnosed with Threatened Premature Labor, Cervical Incompetency, Premature Rupture of the Membranes, Placenta Previa, Threatened Uterine Rupture, Hypertensive Disorders of Pregnancy and Fetal Growth Restriction

Interventions

The intervention group will be receiving the midwifery care program. This care program comprises six individual 30-minute sessions addressing perinatal-specific anxiety during pregnancy and the first
s own birthing experiences that lead to preterm birth. The control group will be offered usual care.

Sponsors

Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: This study will include only singleton pregnancies. Upon admission, the pregnant woman must be between 24 and 35 weeks' gestation. Additionally, fetal well-being has been confirmed.

Exclusion criteria

Exclusion criteria: This study will exclude pregnant women with psychiatric complications, multiple gestations, fetal diseases, or who are unable to communicate in Japanese.

Design outcomes

Primary

MeasureTime frame
The change in State-Trait Anxiety Inventory (STAI) scores before and after the midwifery care intervention is calculated as the mean difference between the two groups.

Countries

Japan

Contacts

Public ContactChie Tanii

Tokyo Women's Medical University Yachiyo Medical Center Nursing Department

tanii.chie@twmu.ac.jp047-450-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026