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

NCT07323459 | Not Yet Recruiting

• 1 other identifier: KB/367/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prenatal care; pregnancy-related anxiety; maternal mental health; anxiety; pregnancy

Outcome Measures

Primary Outcomes (1)

• Pregnancy-Related Anxiety Level

  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.

  Baseline (Session 1, before intervention start) and post-intervention (after completing 4-6 sessions, approximately 8-12 weeks from baseline)

Study Arms (2)

Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention

EXPERIMENTAL

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

Standard prenatal care without additional psychoeducational intervention

NO INTERVENTION

Interventions

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

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.

Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Division of Obstetric and Gynaecological Nursing, Faculty of Health Sciences with the Institute of Maritime and Tropical Medicine, Medical University of Gdańsk

Gdansk, 80-210, Poland

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Aleksandra Krawczyk

CONTACT

+48 539 707 706; a.krawczyk@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)