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Starting soon Not applicable

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

NCT07323459 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-01-07

Condition(s) studied

Pregnancy-Related Anxiety (PrA)Fear of Childbirth

Investigational drug(s) / intervention(s)

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

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.

Study 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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pregnant women in the second or third trimester of pregnancy * Elevated level of pregnancy-related anxiety (PrA) * Low obstetric risk pregnant women (no significant medical contraindications to vaginal delivery) * Consent to participate in individual psychoeducational sessions * Ability to communicate in Polish at a level sufficient to understand the materials and participate in the sessions Exclusion Criteria: * Pregnant women with severe mental disorders requiring urgent psychiatric intervention * Women with serious obstetric complications in the current pregnancy requiring intensive medical monitoring (e.g., severe hypertension, imminent preterm delivery requiring hospitalization) * Patients already undergoing intensive psychotherapy or pharmacotherapy for anxiety * Lack of consent to participate or inability to attend sessions (e.g., due to logistical reasons) * Pregnant women whose pregnancy-related anxiety is not the primary concern, with other dominant anxiety disorders (e.g., GAD unrelated to pregnancy) or other priority health needs

Primary outcome measure(s)

  • Pregnancy-Related Anxiety Level — Baseline (Session 1, before intervention start) and post-intervention (after completing 4-6 sessions, approximately 8-12 weeks from baseline)
    Measure: Change in Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) total score from baseline to post-intervention. Description: The PRAQ-R2 is a validated 10-item questionnaire assessing pregnancy-specific anxiety, using a 5-point Likert scale. Total scores range from 10 to 50, with higher scores indicating higher levels of pregnancy-related anxiety (worse outcome). The Polish validated version of the questionnaire will be used. A decrease in score reflects a reduction in anxiety.

Trial sites (1)

FacilityCityRegionStatus
Division of Obstetric and Gynaecological Nursing, Faculty of Health Sciences with the Institute of Maritime and Tropical Medicine, Medical University of Gdańsk Gdansk Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07323459 on ClinicalTrials.gov ↗ ← All trials in Poland