Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT04929561
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Breastfeeding Support Provided Via Video-conferencing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean postpartum maternal anxiety level (mean ± SD)', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'The primary outcome of this study was the mean postpartum maternal anxiety level (mean ± SD) of the mothers at 2 weeks and 4 weeks after delivery. Maternal anxiety level was assessed using the Postpartum Specific Anxiety Scale. The scale comprises 51 items and 4 sub-dimensions. It means that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.'}, {'measure': 'The mean breastfeeding self-efficacy level', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'The other main outcome of the study was the mean breastfeeding self-efficacy level (mean ± SD) measured with the Breastfeeding Self-Efficacy Scale Short Form. The scale is likert type and a total score between 14 and 70 is taken from the scale. The higher the score, the higher the breastfeeding self-efficacy.'}], 'secondaryOutcomes': [{'measure': 'Neonatal outcomes-Newborn weight (g)', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery'}, {'measure': 'Neonatal outcomes-Hypoglycemia of the newborn', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.'}, {'measure': 'Neonatal outcomes-Need for phototherapy', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery'}, {'measure': 'Neonatal outcomes-Respiratory morbidity', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery'}, {'measure': 'Neonatal outcomes-illness requiring hospitalization', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery'}, {'measure': 'Neonatal outcomes-Food intake other than breast milk', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery'}, {'measure': 'Neonatal outcomes-Neonatal death', 'timeFrame': 'at 2 weeks and 4 weeks after delivery', 'description': 'Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastfeeding', 'Anxiety Disorders', 'Neonatal Outcomes']}, 'descriptionModule': {'briefSummary': 'A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInfants;\n\n* Born between 37 and 42 weeks\n* Without severe congenital anomalies\n\nMothers;\n\n* A single live birth\n* Were 18 years of age or over\n* At least primary school graduate\n* Did not have a disease that prevents breastfeeding\n* Had internet access at home or on the phone\n* Could speak and understand the Turkish language.\n\nExclusion Criteria:\n\n* Situations that cause separation of mother and baby\n* Hospitalization of the baby in intensive care\n* Inability to answer 3 calls in a video call\n* They were determined as those who could not be reached during the home visit for the first and second follow'}, 'identificationModule': {'nctId': 'NCT04929561', 'briefTitle': 'The Effect of Breastfeeding Support Provided Via Video-conferencing', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Breastfeeding Support'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video-conferencing group', 'description': "The mothers in the video-conferencing group were counseled via video-conferencing a total of six times (three times a week, at equal intervals) during the first 2 weeks after birth. Each interview was approximately 15-20 minutes. In video-conferencing sessions, the breastfeeding position, the mother's grasping the breast, the baby's latch-on, and sucking duration were observed. Mothers' questions were answered and solutions were offered for breastfeeding problems (sore nipple, engorgement, etc.).", 'interventionNames': ['Behavioral: Video-conferencing group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The mothers in the control group were given usual care before discharge and no intervention was made after discharge.'}], 'interventions': [{'name': 'Video-conferencing group', 'type': 'BEHAVIORAL', 'otherNames': ['Control group'], 'description': 'No intervention', 'armGroupLabels': ['Video-conferencing group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Kahramanmaraş', 'state': 'Kahramanmaraş', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Deniz Akyıldız', 'role': 'CONTACT', 'email': 'denizbtm@gmail.com', 'phone': '05069851358'}], 'facility': 'Kahramanmaras Sutcu Imam University', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'centralContacts': [{'name': 'Deniz Akyıldız, PhD', 'role': 'CONTACT', 'email': 'denizbtm@gmail.com', 'phone': '05069851358'}, {'name': 'Deniz Akyıldız', 'role': 'CONTACT', 'email': 'denizbtm@gmail.com', 'phone': '05069851358'}], 'overallOfficials': [{'name': 'Betül Bay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kahramanmaras Sutcu Imam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Deniz Akyıldız', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}