Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
Study NCT ID:
NCT06290700
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of maternal function by Barkin Index of Maternal Functioning', 'timeFrame': '10 weeks after after the intervention', 'description': 'The scale was used 6 weeks after childbirth'}], 'secondaryOutcomes': [{'measure': 'Maternal Postpartum Quality of Life Instrument', 'timeFrame': '10 weeks after after the intervention', 'description': 'The scale was used 6 weeks after childbirth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['functional status', 'life quality', 'mothers', 'Pregnancy'], 'conditions': ['Life Quality', 'Functional Status']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life.', 'detailedDescription': 'This was a single blind randomised controlled experimental study. The sample size of the study was calculated using the G\\*Power 3.1.7 program, considering a 5% margin of error and 95% confidence interval, and was determined to be at least 61. Therefore, the sample was planned to consist of 122 pregnant women, including 61 pregnant women in the intervention group and 61 pregnant women in the control group.\n\nStudy Inclusion Criteria Being at least a primary school graduate. Being a primiparous pregnant woman. Being able to provide feedback. Study Exclusion Criteria Being a multiparous pregnant woman. Being a high-risk pregnant woman. Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being at least a primary school graduate.\n* Being a primiparous pregnant woman.\n* Being able to provide feedback.\n\nExclusion Criteria:\n\n* Being a multiparous pregnant woman.\n* Being a high-risk pregnant woman.'}, 'identificationModule': {'nctId': 'NCT06290700', 'briefTitle': 'Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Celal Bayar University'}, 'officialTitle': 'Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life: Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'MCBU_2880'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'İntervational group', 'description': 'Neonatal care education given to primiparous pregnant women affect their postpartum maternal function Neonatal care education given to primiparous pregnant women affect their postpartum quality of life?', 'interventionNames': ['Behavioral: Neonatal Care education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'All pregnant women, those in the control group, were provide with standard'}], 'interventions': [{'name': 'Neonatal Care education', 'type': 'BEHAVIORAL', 'description': 'Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.', 'armGroupLabels': ['İntervational group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manisa', 'country': 'Turkey (Türkiye)', 'facility': 'Yonca ÇIÇEK OKUYAN', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celal Bayar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}