A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women.
- Who it may be relevant to
- Registry conditions: Pregnancy-Related Anxiety (PrA), Fear of Childbirth. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women
Overview
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
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
Primary outcome measures
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Poland · 1 center
- Division of Obstetric and Gynaecological Nursing, Faculty of Health Sciences with the Inst — Gdansk
Publications
- 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. PMID 42317977
Identifiers
NCT: NCT07323459 · KB/367/2025