[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617810":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":22,"locations":28,"responsibleParty":40,"collaborators":11,"id":42,"slug":11,"hasResults":43,"nctId":44,"briefTitle":19,"officialTitle":45,"acronym":11,"eligibilityCriteria":46,"healthyVolunteers":43,"sex":47,"minAge":48,"maxAge":11,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention","EXPERIMENTAL",null,[13],"Other: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women",{"label":15,"type":16,"description":11,"interventionNames":11},"Standard prenatal care without additional psychoeducational intervention","NO_INTERVENTION",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women","Individual program by midwife in 2nd\u002F3rd trimester: 4-6 sessions (\\~60min), every 1-2 weeks.\n\nSession 1: PRAQ-R2 assessment, identifying fears, building trust. Session 2: Labor stages education, myth verification, visual aids. For multiparous: previous birth discussion.\n\nSession 3: Pain management - breathing, relaxation, massage, hydrotherapy, epidural, nitrous oxide. Practical exercises.\n\nSession 4: Birth plan development, assertive communication training, role-playing.\n\nSession 5: Mindfulness, cognitive restructuring, affirmations, visualization, final PRAQ-R2.\n\nSession 6 (optional): Techniques review, birth plan finalization, Q\\&A, contact plan.\n\nMaterials: brochures, diagrams, videos, templates, audio instructions. Flexible, individualized.",[9],[23],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Aleksandra Krawczyk","CONTACT","+48 539 707 706","a.krawczyk@gumed.edu.pl",[29],{"facility":30,"status":11,"city":31,"state":11,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":11},"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",{"type":35,"coordinates":36},"Point",[37,38],18.64912,54.35227,{"lat":38,"lon":37},{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100617810",false,"NCT07323459","Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women","Inclusion Criteria:\n\n* Pregnant women in the second or third trimester of pregnancy\n* Elevated level of pregnancy-related anxiety (PrA)\n* Low obstetric risk pregnant women (no significant medical contraindications to vaginal delivery)\n* Consent to participate in individual psychoeducational sessions\n* Ability to communicate in Polish at a level sufficient to understand the materials and participate in the sessions\n\nExclusion Criteria:\n\n* Pregnant women with severe mental disorders requiring urgent psychiatric intervention\n* Women with serious obstetric complications in the current pregnancy requiring intensive medical monitoring (e.g., severe hypertension, imminent preterm delivery requiring hospitalization)\n* Patients already undergoing intensive psychotherapy or pharmacotherapy for anxiety\n* Lack of consent to participate or inability to attend sessions (e.g., due to logistical reasons)\n* 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","FEMALE","18 Years",{"count":50,"type":51},80,"ESTIMATED","INTERVENTIONAL",[54],"NA","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:\n\n* Can individualized midwife-led psychoeducation significantly reduce pregnancy-related anxiety levels as measured by the PRAQ-R2 questionnaire?\n* Does this intervention improve women's sense of control, competence, and readiness for childbirth?\n* Can the intervention reduce preferences for cesarean section without medical indication among low-risk pregnant women?\n\nParticipants will:\n\n* Attend 4-6 individual sessions (approximately 60 minutes each) with a midwife, scheduled every 1-2 weeks\n* Complete the Pregnancy-Related Anxiety Questionnaire (PRAQ-R2) at the beginning and end of the intervention to measure anxiety levels\n* Receive evidence-based education about the physiological process of childbirth, pain management methods (both pharmacological and non-pharmacological), and medical procedures\n* Learn and practice stress-reduction techniques including breathing exercises, relaxation methods, and mindfulness\n* Develop an individualized birth plan and practice communication skills for effective interaction with medical personnel\n* Work on cognitive strategies to address negative thoughts and build positive affirmations about childbirth",[57,58],"Pregnancy-Related Anxiety (PrA)","Fear of Childbirth",[60,61,62,63,64],"prenatal care","pregnancy-related anxiety","maternal mental health","anxiety","pregnancy","NOT_YET_RECRUITING","2025-12-31",{"date":68,"type":69},"2026-01-07","ACTUAL",{"date":71,"type":51},"2026-01-01",{"date":73,"type":51},"2028-02-28",{"name":5,"class":6},1]