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

NCT ID: NCT07323459

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Standard prenatal care without additional psychoeducational intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Gdansk, , Poland

Countries

Poland

Central Contacts

Aleksandra Krawczyk

Role: CONTACT

a.krawczyk@gumed.edu.pl

+48 539 707 706

Other Identifiers

KB/367/2025

Identifier Type: -

Identifier Source: org_study_id