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

NCT07323459 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-07

No results posted yet for this 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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-02-28
Completion
2028-02-28

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07323459 on ClinicalTrials.gov