Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-02 @ 12:48 AM
Study NCT ID:
NCT06384768
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Training on Pre-Pregnancy Fear of Birth in Male Partners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear of Childbirth', 'timeFrame': 'From enrollment to the end of the training at 4 weeks', 'description': 'Pre-pregnancy fear of childbirth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fear', 'birth', 'pregnancy', 'male', 'online support'], 'conditions': ['Fear of Childbirth']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \\"Descriptive Information Form\\" and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training\'s appeal for male partners.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Men who have non-pregnant wives.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(i) must be married (ii) must be male gender (iii) must participate voluntarily\n\nExclusion Criteria:\n\n(i) to have a spouse who had been previously pregnant or having a living child.'}, 'identificationModule': {'nctId': 'NCT06384768', 'briefTitle': 'Video Training on Pre-Pregnancy Fear of Birth in Male Partners', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Effect of Video Training on Pre-Pregnancy Fear of Birth in Male Partners: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'EBIst'}, 'secondaryIdInfos': [{'id': '1919B012104428', 'type': 'OTHER_GRANT', 'domain': 'TUBITAK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The arm that which was given an online video training', 'interventionNames': ['Other: Video training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention was applied'}], 'interventions': [{'name': 'Video training', 'type': 'OTHER', 'description': 'A 4 week support program consist of videos for fear of childbirth', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istinye University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethical reasons'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Elif Balkan', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}