NCT07323459

A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women

Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether an individualized psychoeducational intervention led by an experienced midwife can reduce pregnancy-related anxiety (PrA) in pregnant women during the second and third trimesters. The main questions it aims to answer are: * Can individualized midwife-led psychoeducation significantly reduce pregnancy-related anxiety levels as measured by the PRAQ-R2 questionnaire? * Does this intervention improve women's sense of control, competence, and readiness for childbirth? * Can the intervention reduce preferences for cesarean section without medical indication among low-risk pregnant women? Participants will: * Attend 4-6 individual sessions (approximately 60 minutes each) with a midwife, scheduled every 1-2 weeks * Complete the Pregnancy-Related Anxiety Questionnaire (PRAQ-R2) at the beginning and end of the intervention to measure anxiety levels * Receive evidence-based education about the physiological process of childbirth, pain management methods (both pharmacological and non-pharmacological), and medical procedures * Learn and practice stress-reduction techniques including breathing exercises, relaxation methods, and mindfulness * Develop an individualized birth plan and practice communication skills for effective interaction with medical personnel * Work on cognitive strategies to address negative thoughts and build positive affirmations about childbirth

Conditions

• Pregnancy-Related Anxiety (PrA)
• Fear of Childbirth

Interventions

Type	Name	Description
OTHER	A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women	Individual program by midwife in 2nd/3rd trimester: 4-6 sessions (\~60min), every 1-2 weeks. Session 1: PRAQ-R2 assessment, identifying fears, building trust. Session 2: Labor stages education, myth verification, visual aids. For multiparous: previous birth discussion. Session 3: Pain management - breathing, relaxation, massage, hydrotherapy, epidural, nitrous oxide. Practical exercises. Session 4: Birth plan development, assertive communication training, role-playing. Session 5: Mindfulness, cognitive restructuring, affirmations, visualization, final PRAQ-R2. Session 6 (optional): Techniques review, birth plan finalization, Q\&A, contact plan. Materials: brochures, diagrams, videos, templates, audio instructions. Flexible, individualized.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-02-28
• Completion: 2028-02-28
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Poland