Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:34 PM
Study NCT ID:
NCT07471269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Pain Neuroscience Education For Fear Of Childbirth.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064186', 'term': 'Prenatal Education'}], 'ancestors': [{'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear of childbirth', 'timeFrame': '4 weeks', 'description': 'The Wijma Delivery Expectancy Questionnaire (W-DEQ) version A, validated in Spanish, has shown excellent psychometric properties. This instrument consists of 33 items scored from 1 to 6, with higher scores indicating greater fear of childbirth.'}], 'secondaryOutcomes': [{'measure': 'Pain catastrophizing', 'timeFrame': '4 weeks', 'description': 'The pain catastrophizing scale is an instrument made up of 13 items (each item scores between 0 and 4), which measures the degree to which patients develop feelings and thoughts related to their nociceptive experience. This scale, which has a validated version for Spanish, shows adequate internal consistency.'}, {'measure': 'Anxiety and depression', 'timeFrame': '4 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS) questionnaire will be used. This consists of 14 questions, of which 7 assess symptoms of anxiety (HADS-A) and 7 measure symptoms of depression (HADS-D). Each item scores from 0 to 3, with a score range in each subscale from 0-21. Scores of 0-7 indicate no anxiety or depression; scores between 8-10 indicate medium levels; scores of 11-14 indicate moderate levels and scores of 15-21 indicate severe levels of anxiety or depression. The HADS scale has good internal consistency, reliability, and validity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fear of childbirth', 'pregnancy', 'pain neuroscience education', 'prenatal education'], 'conditions': ['Fear of Childbirth']}, 'descriptionModule': {'briefSummary': 'Fear of childbirth ranges from mild worry to severe anxiety and affects women of all ages. It is often linked to perceiving childbirth as unpredictable and painful. Women cope by seeking support, practicing relaxation, or attending prenatal education, with information playing a key role in reducing anxiety and increasing confidence.\n\nPain neuroscience education has shown benefits in reducing pain, anxiety, and related fears by teaching the neurobiological mechanisms underlying pain.', 'detailedDescription': 'Fear of childbirth is a psychological condition that can range from mild fear to extreme anxiety about childbirth. It can affect women of all ages, whether they are pregnant or not, and is often associated with the perception of childbirth as an unpredictable and painful process.\n\nTo cope with this fear, many women seek emotional and professional support, practice relaxation techniques, or participate in prenatal education. In this context, access to appropriate information can help reduce anxiety and strengthen confidence, promoting more positive childbirth experiences.\n\nAmong educational strategies, education in the neuroscience of pain has gained increasing attention in recent years due to its positive effects on reducing pain, pain catastrophizing, kinesiophobia, anxiety, and depression. This approach is based on reconceptualizing pain through the teaching of the neurobiological mechanisms underlying the pain experience.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women over 18 years of age, primiparous or multiparous.\n* At the beginning of the third trimester of pregnancy\n\nExclusion Criteria:\n\n* Multiple pregnancies.\n* Previous spinal surgery.\n* Psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT07471269', 'briefTitle': 'Online Pain Neuroscience Education For Fear Of Childbirth.', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Effectiveness Of An Online Pain Neuroscience Education Intervention In Reducing Fear Of Childbirth Among Pregnant Women.', 'orgStudyIdInfo': {'id': 'UNIVERSITY CARDENAL HERRERA-71'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain neuroscience education (PNE)', 'description': "The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler \\& Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.", 'interventionNames': ['Other: Pain neuroscience education', 'Other: Prenatal education']}, {'type': 'EXPERIMENTAL', 'label': 'Prenatal education (PE)', 'description': 'Patients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.', 'interventionNames': ['Other: Prenatal education']}], 'interventions': [{'name': 'Pain neuroscience education', 'type': 'OTHER', 'description': "The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 Pain neuroscience education lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler \\& Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.", 'armGroupLabels': ['Pain neuroscience education (PNE)']}, {'name': 'Prenatal education', 'type': 'OTHER', 'description': 'The standard prenatal education is based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.', 'armGroupLabels': ['Pain neuroscience education (PNE)', 'Prenatal education (PE)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'JF Lisón, Dr', 'role': 'CONTACT', 'email': 'juanfran@uchceu.es', 'phone': '0034606503108'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Juan F. Lisón Párraga, Dr', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}