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Study protocol for a midwife-led psychoeducational intervention to reduce pregnancy-related anxiety in low-risk
Aleksandra Krawczyk1, Agnieszka Czerwińska-Osipiak1, Lucyna Wójcicka1
1Division of Obstetric and Gynaecological Nursing, Faculty of Health Sciences With the Institute of Maritime and Tropical Medicine, Medical University of Gdańsk, Gdańsk, Poland.
Introduction:
Pregnancy-related anxiety is a distinct form specifically focused on perinatal concerns, including the course of pregnancy, childbirth and parenthood. Despite its clinical significance, pregnancy-related anxiety remains underrecognised in routine antenatal care. Poland has one of the highest caesarean section rates in Europe, with maternal fear of childbirth and anxiety-driven preferences for operative birth identified as major contributing factors. The aim of this study is to evaluate whether an individual, midwife-led psychoeducational intervention delivered in the second and third trimester reduces pregnancy-related anxiety.
Materials And Methods:
This is a two-arm, parallel-group randomised controlled trial with a 1:1 allocation ratio. A total of 74 low-risk pregnant women with elevated pregnancy-related anxiety (PRAQ-R2 score ≥30 points) will be recruited from antenatal clinics, childbirth education schools and online platforms. The intervention group will receive four to six individual psychoeducational sessions delivered by a trained midwife between 24 and 34 weeks of gestation, focusing on childbirth education, pain management, communication skills, birth planning and anxiety management techniques. The control group will receive standard antenatal care and an informational booklet. The primary outcome is the reduction in pregnancy-related anxiety levels measured via the Pregnancy-Related Anxiety Questionnaire - Revised 2 between 34 and 37 weeks. Secondary outcomes include actual mode of birth and childbirth satisfaction, as well as maternal and neonatal health outcomes. Data will be collected at three time points and analysed using intention-to-treat principles.
Discussion:
This trial will provide initial evidence on the effectiveness of a scalable, midwife-delivered psychoeducational intervention tailored to the Polish perinatal context. If proven effective, the programme could improve maternal psychological wellbeing and strengthen the role of midwives in antenatal mental healthcare. The findings may inform future policy changes and perinatal care standards in Poland and other countries with similarly high caesarean section rates and fragmented maternity care systems.
Clinical Trial Registration:
ClinicalTrials.gov, identifier NCT07323459.
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