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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention | Experimental |
| |
| Standard prenatal care without additional psychoeducational intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksandra Krawczyk | Contact | +48 539 707 706 | a.krawczyk@gumed.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42317977 | Derived | Krawczyk A, Czerwinska-Osipiak A, Wojcicka L, Michalik A, Gruszecka A. Study protocol for a midwife-led psychoeducational intervention to reduce pregnancy-related anxiety in low-risk pregnant women. Front Public Health. 2026 Jun 3;14:1832201. doi: 10.3389/fpubh.2026.1832201. eCollection 2026. |
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IPD will not be shared to protect participant confidentiality and due to data protection regulations. Results will be published in aggregated form.
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|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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