Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT05812833
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2022-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Education', 'timeFrame': '16 weeks', 'description': "Web-based online baby care training based on Meleis' Transition Theory to measures mothers' self-confidence"}, {'measure': 'Newborn', 'timeFrame': '16 weeks', 'description': "To evaluate more successful breastfeeding in infants of mothers who received web-based online infant care training based on Meleis' Transition Theory."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meleis Transition Theory', 'infant health', 'online education', 'web page'], 'conditions': ['Newborn; Vitality', 'Theory, Double Bind', 'Mother-Infant Interaction']}, 'referencesModule': {'references': [{'pmid': '39900549', 'type': 'DERIVED', 'citation': "Bilgic FS, Bozkurt G. The Effect of Online Infant Care Education and Postpartum Counseling Based on Meleis's Transition Theory on Mothers' Self-Esteem and Infant Health: A Randomized Controlled Trial. Nurs Health Sci. 2025 Mar;27(1):e70045. doi: 10.1111/nhs.70045."}]}, 'descriptionModule': {'briefSummary': "Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health", 'detailedDescription': "When the mother is not self-confident; They cannot fulfill their motherhood role, have difficulty in establishing a relationship with their baby, and cannot raise their babies in a healthy way. It is easier for mothers who have the necessary knowledge and skills to care for the baby to adapt to this process. The educational support given in the transition to motherhood will affect the mother's self-confidence and readiness for motherhood, thus affecting the baby's health.\n\nThe research will be conducted on the online platform between November 2022 and November 2023. The population of the randomized controlled study was Istanbul Haseki Training and Research Hospital Sultan Gazi Haseki Campus, the pregnant women followed in the pregnant outpatient clinic, the sample was n: 45 pregnant women who attended the online training meeting the sample selection criteria, 45 pregnant women informed on the website, and 45 pregnant women in the control group, a total of 135 mothers. will form the candidate. Pregnant women who are willing to participate in the study will be assigned to the groups by simple randomization method. During the research, the CONSORT 2018 statement will be followed. Research data; Data Collection Form will be obtained by Pregnants' Readiness for Newborn Hygienic Care Scale, Karitane Parental Self-Confidence Scale, LACTH (Breastfeeding Success Assessment) Scale and Infant Follow-up Form."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Mother', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous pregnant\n* Single pregnancy\n* Expectant mothers with internet access,\n* Expectant mothers who can use digital tools (Smartphone or computer)\n* Mothers with healthy babies\n* Mothers whose babies were born at term (between 37-42 GH)\n* Mothers discharged with their baby\n* Those whose baby is with the mother\n* Expectant mothers who do not attend pregnancy education classes\n\nExclusion Criteria:\n\n* The mother has communication problems,\n* The mother has a chronic illness,\n* Having problems with breastfeeding (breast or newborn),\n\n * The newborn has IUGR or genetic disease,\n * Failure to attend training sessions.'}, 'identificationModule': {'nctId': 'NCT05812833', 'briefTitle': "Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health", 'organization': {'class': 'OTHER', 'fullName': 'Halic University'}, 'officialTitle': "The Effect of Web-Based Baby Care Education Based on Meleis' Transition Theory on Mother's Self-Confidence and Newborn Health", 'orgStudyIdInfo': {'id': 'PhD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participating in online training and providing active consultancy', 'description': 'Online training will be given to mothers, and then the web link will be shared and online counseling will be given every week. Mothers will be followed for 3 months', 'interventionNames': ['Behavioral: Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Will receive routine maintenance of the institution'}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'otherNames': ['consultancy'], 'description': 'Pregnant women will be given online baby care training', 'armGroupLabels': ['Participating in online training and providing active consultancy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fatih', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatma Şule Tanrıverdi, Msc', 'role': 'CONTACT', 'email': 'sulebilgic@halic.edu.tr', 'phone': '5413606482'}], 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.0225, 'lon': 28.94083}}], 'centralContacts': [{'name': 'Gülçin Bozkurt, Prof', 'role': 'CONTACT', 'email': 'gulmeh@hotmail.com', 'phone': '5414679620', 'phoneExt': '12220'}, {'name': 'Berker Okay, MD', 'role': 'CONTACT', 'email': 'drberkerokay@hotmail.com', 'phone': '5556276571'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Research data collection: 6 months Analysis of data: 3 Months Reporting and publication preparation: 3 Months'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gülçin Bozkurt', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Fatma Şule Bilgiç', 'investigatorAffiliation': 'Halic University'}}}}