Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:08 AM
Study NCT ID:
NCT07323459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-31', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-31', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy-Related Anxiety Level', 'timeFrame': 'Baseline (Session 1, before intervention start) and post-intervention (after completing 4-6 sessions, approximately 8-12 weeks from baseline)', 'description': 'Measure: Change in Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) total score from baseline to post-intervention.\n\nDescription: 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prenatal care', 'pregnancy-related anxiety', 'maternal mental health', 'anxiety', 'pregnancy'], 'conditions': ['Pregnancy-Related Anxiety (PrA)', 'Fear of Childbirth']}, 'descriptionModule': {'briefSummary': "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"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07323459', 'briefTitle': 'A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women', 'orgStudyIdInfo': {'id': 'KB/367/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention', 'interventionNames': ['Other: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women']}, {'type': 'NO_INTERVENTION', 'label': 'Standard prenatal care without additional psychoeducational intervention'}], 'interventions': [{'name': 'A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women', 'type': 'OTHER', 'description': 'Individual program by midwife in 2nd/3rd 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.', 'armGroupLabels': ['Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-210', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Division of Obstetric and Gynaecological Nursing, Faculty of Health Sciences with the Institute of Maritime and Tropical Medicine, Medical University of Gdańsk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'centralContacts': [{'name': 'Aleksandra Krawczyk', 'role': 'CONTACT', 'email': 'a.krawczyk@gumed.edu.pl', 'phone': '+48 539 707 706'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared to protect participant confidentiality and due to data protection regulations. Results will be published in aggregated form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}