Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-30 @ 6:41 AM
Study NCT ID:
NCT07252466
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Affecting Postnatal Mother-To-Infant Bonding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MIBS level', 'timeFrame': 'Immediately after completion of the first breastfeeding', 'description': 'After the first breastfeeding experience was completed, the mother assessed based on the mothers\' self-reports using the Mother-Infant Bonding Scale (MIBS). The "MIBS", developed by Taylor et al., was used to assess mother-to-infant bonding following the first breastfeeding. The MIBS consists of 8 items rated on a 4-point Likert scale (0-3). Items 1, 4, and 6 assess positive emotions (scored as 0, 1, 2, 3), while items 2, 3, 5, 7, and 8 assess negative emotions (scored as 3, 2, 1, 0). Total scores range from 0 to 24, with lower scores indicating stronger mother-infant bonding. The tool has no specific cut-off value and has been shown to be sensitive in detecting subtle variations in early maternal bonding.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postnatal', 'bonding', 'infant', 'mothers-infant bonding'], 'conditions': ['Postpartum', 'Bonding', 'Newborn']}, 'referencesModule': {'references': [{'pmid': '35911218', 'type': 'RESULT', 'citation': 'Hailemeskel HS, Kebede AB, Fetene MT, Dagnaw FT. Mother-Infant Bonding and Its Associated Factors Among Mothers in the Postpartum Period, Northwest Ethiopia, 2021. Front Psychiatry. 2022 Jul 13;13:893505. doi: 10.3389/fpsyt.2022.893505. eCollection 2022.'}, {'pmid': '30849963', 'type': 'RESULT', 'citation': 'Nakano M, Upadhyaya S, Chudal R, Skokauskas N, Luntamo T, Sourander A, Kaneko H. Risk factors for impaired maternal bonding when infants are 3 months old: a longitudinal population based study from Japan. BMC Psychiatry. 2019 Mar 8;19(1):87. doi: 10.1186/s12888-019-2068-9.'}, {'pmid': '28842556', 'type': 'RESULT', 'citation': 'Ohara M, Okada T, Aleksic B, Morikawa M, Kubota C, Nakamura Y, Shiino T, Yamauchi A, Uno Y, Murase S, Goto S, Kanai A, Masuda T, Nakatochi M, Ando M, Ozaki N. Social support helps protect against perinatal bonding failure and depression among mothers: a prospective cohort study. Sci Rep. 2017 Aug 25;7(1):9546. doi: 10.1038/s41598-017-08768-3.'}, {'pmid': '15868385', 'type': 'RESULT', 'citation': 'Taylor A, Atkins R, Kumar R, Adams D, Glover V. A new Mother-to-Infant Bonding Scale: links with early maternal mood. Arch Womens Ment Health. 2005 May;8(1):45-51. doi: 10.1007/s00737-005-0074-z. Epub 2005 May 4.'}, {'pmid': '31550274', 'type': 'RESULT', 'citation': 'Tichelman E, Westerneng M, Witteveen AB, van Baar AL, van der Horst HE, de Jonge A, Berger MY, Schellevis FG, Burger H, Peters LL. Correlates of prenatal and postnatal mother-to-infant bonding quality: A systematic review. PLoS One. 2019 Sep 24;14(9):e0222998. doi: 10.1371/journal.pone.0222998. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the factors that affect the postnatal mother-to-infant bonding.', 'detailedDescription': "Bonding is recognised as one of the fundamental processes in terms of the socio-emotional development of the infants and the relationship they establish with the outside world.Mother-to-infant bonding typically initiates during pregnancy and continues to evolve through early childhood, reflecting the mother's emotional orientation toward her infant. The initial postnatal period is the most favourable time for the initiation of a positive mother-to-infant relationship and bonding.An adequate mother-to-infant bonding contributes to the positive physical and socio-emotional development of the child. A weaker mother-to-infant bonding is associated with insecure attachment and depression and anxiety in children. Also, women with weaker mother-to-infant bonding have been found to show less interest in the health of their children. These behaviours cause long-term negative cognitive and socio-emotional development in the child.In a study that assessed the level of mother-to-infant bonding in the postnatal period and the associated factors, in general, a significant proportion of mothers had difficulties in mother-to-infant bonding in the postnatal period. The postpartum period is a critical, complicated period of transition for both the mother and the infant, considering psychological, social, and physiological difficulties. Therefore, the mother-to-infant bonding can be affected by many factors. The aim of this study is to determine the factors that affect the postnatal mother-to-infant bonding."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Mothers who give birth at the Maternity and Children's Hospital and their infants", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All healthy mothers who applied to the hospital's maternity ward at the time of the study\n* who had a normal spontaneous delivery\n* infants who were born at ≥38 gestational weeks\n* infants who were deemed healthy by the physician were included in the study.\n\nExclusion Criteria:\n\n* Mothers who had a risky health problem during delivery\n* Infants who had a congenital illness"}, 'identificationModule': {'nctId': 'NCT07252466', 'briefTitle': 'Factors Affecting Postnatal Mother-To-Infant Bonding', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Factors Affecting Postnatal Mother-To-Infant Bonding: A Modelling Study', 'orgStudyIdInfo': {'id': '62/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Term newborn-mother group', 'description': 'The group consists of mothers who gave birth at the hospital where the study was conducted during the data collection period and were found to be eligible to participate in the study, along with their infants. No intervention was performed on the mothers or infants.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention was performed on the mothers or infants.', 'armGroupLabels': ['Term newborn-mother group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34750', 'city': 'Istanbul', 'state': 'Ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Acıbadem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Merve Coşkun, Assist.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibadem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Zehra Kan Onturk', 'investigatorAffiliation': 'Acibadem University'}}}}