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NCT Number: NCT07323459

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

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

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Key information

Conditions

Pregnancy-Related Anxiety (PrA) Anxiety Disorders Fear of Childbirth Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Pregnancy-Related Anxiety Level

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandra Krawczyk

CONTACT

[email protected]

+48 539 707 706

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jan 7, 2026
Registry last updated: Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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