Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:13 AM
Study NCT ID:
NCT07467304
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-12
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nursing Education Provided After Cesarean Section Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spielberger State-Trait Anxiety Inventory (STAI):', 'timeFrame': '12 weeks', 'description': 'Spielberger State-Trait Anxiety Inventory (STAI): The state anxiety inventory determines how a person feels at a specific time. The scale is answered on a scale of "1 (none), 2 (somewhat), 3 (a lot), 4 (completely)" according to the intensity of the individual\'s feelings at that moment. The trait anxiety inventory, on the other hand, determines how the individual generally feels and is answered on a scale of "1 (almost never), 2 (sometimes), 3 (most of the time), 4 (always)". The state anxiety scale has 10 reverse items, and the trait anxiety scale has 7 reverse items. To calculate the scale score, the total score obtained from the direct items is subtracted from the total score obtained from the reverse items. A constant value of 50 for the state anxiety scale and 35 for the trait anxiety scale is added to the resulting number. The possible score ranges from 20 to 80. The average score is between 36 and 41. As the score increases, the level of anxiety also increases.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '12 weeks', 'description': 'The VAS is used to convert certain values that cannot be measured quantitatively into numerical values. It is a 10 cm scale with pain-free resolution at one end and the most severe pain possible at the other. In the VAS, which evaluates pain intensity, pain intensity is rated on a scale of 0 to 10. "No pain" is rated as 0 points and "very severe pain" is rated as 10 points. Pain intensity is indicated as "less than 3 points" for mild pain, "between 3-6 points" for moderate pain, and "more than 6 points" for severe pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Birth', 'Patient Education']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effect of individual education given after cesarean section on the levels of pain and anxiety in women in the postoperative period. The research is a randomized controlled trial with an experimental design, featuring a pre-test-post-test control design with experimental and control groups. The study will be conducted at Çorlu State Hospital. Data will be collected by conducting a pre-test within the first 6-12 hours after cesarean section, followed by education, and then a post-test before discharge (24-48 hours later). The Demographic Information Form, Knowledge Test, Spielberger State-Trait Anxiety Inventory, and Visual Analog Scale will be used to collect data.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women were included in the study because they had undergone cesarean section surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-45\n* Women who have undergone cesarean section\n* Women who agreed to participate in the study\n\nExclusion Criteria:\n\n* Women who are not between 18 and 45 years of age\n* Women who have not had a cesarean section\n* Those who did not agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT07467304', 'briefTitle': 'Nursing Education Provided After Cesarean Section Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'The Effect Of Nursing Education Provided After Cesarean Section Surgery on Postoperative Pain and Anxiety Levels: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DERDEN-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group- Routine care', 'description': 'Rutin care group', 'interventionNames': ['Other: Placebo Comparator: Control Group- Routine care']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Intervention group - Training group', 'description': 'Group receiving routine care and nursing training.', 'interventionNames': ['Other: Experimental: Experimental: Intervention group - Training group']}], 'interventions': [{'name': 'Experimental: Experimental: Intervention group - Training group', 'type': 'OTHER', 'description': 'Group receiving routine care and nursing training.', 'armGroupLabels': ['Experimental: Intervention group - Training group']}, {'name': 'Placebo Comparator: Control Group- Routine care', 'type': 'OTHER', 'description': 'Rutin care group', 'armGroupLabels': ['Control Group- Routine care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59030', 'city': 'Tekirdağ', 'state': 'Namık Kemal Street', 'country': 'Turkey (Türkiye)', 'facility': 'Tekirdag Namık Kemal University', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}], 'overallOfficials': [{'name': 'DİLEK ERDEN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Namik Kemal University'}, {'name': "Esra Yılmaz, Master's student", 'role': 'STUDY_CHAIR', 'affiliation': 'Namik Kemal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data obtained from the study may be requested from researchers for a reasonable reason.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor (Dr.)', 'investigatorFullName': 'Dilek Erden', 'investigatorAffiliation': 'Namik Kemal University'}}}}