Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:16 AM
Study NCT ID:
NCT07474402
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pretest-posttest randomized experimental study with parallel groups. Participants are randomly assigned either to the intervention group, which receives a multi-component breastfeeding support program, or to the control group, which receives routine postpartum care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale', 'timeFrame': 'Baseline (48 hours postpartum)', 'description': 'Number of Participants Achieving Increased Scores in Breastfeeding Self-Efficacy (14-70, higher = better), LATCH (0-10, higher = better), and Mother-Infant Bonding (19-76, higher = stronger) at 4 Weeks After a Multicomponent Breastfeeding Support Program Following Cesarean Section.'}], 'secondaryOutcomes': [{'measure': 'Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale', 'timeFrame': '4 weeks postpartum follow-up', 'description': 'Number of Participants Achieving Increased Scores in Breastfeeding Self-Efficacy (14-70, higher = better), LATCH (0-10, higher = better), and Mother-Infant Bonding (19-76, higher = stronger) at 4 Weeks After a Multicomponent Breastfeeding Support Program Following Cesarean Section'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Section', 'Breastfeeding Self-Efficacy', 'Maternal-Infant Bonding', 'Breastfeeding Support', 'Postpartum Period'], 'conditions': ['Breastfeeding Self-Efficacy', 'Mother-Infant Attachment', 'Breastfeeding Consultancy Training', 'Primigravida Women']}, 'referencesModule': {'references': [{'pmid': '37635599', 'type': 'RESULT', 'citation': 'Uzunkaya-Oztoprak P, Koc G, Ozyuncu O. The effect of Kinesio Taping on acute pain, breastfeeding behavior and comfort level in women with cesarean section: A randomized controlled trial. Niger J Clin Pract. 2023 Aug;26(8):1075-1084. doi: 10.4103/njcp.njcp_459_22.'}]}, 'descriptionModule': {'briefSummary': 'This study tests a breastfeeding support program for mothers who give birth by cesarean section. The purpose of the study is to see whether the program helps mothers feel more confident about breastfeeding and improves mother-baby bonding.', 'detailedDescription': "Cesarean delivery may negatively affect early breastfeeding initiation, maternal mobility, skin-to-skin contact, and early mother-infant interaction due to postoperative pain, delayed mobilization, and surgical recovery. These factors may reduce maternal confidence in breastfeeding and adversely influence early mother-infant bonding. Therefore, structured and continuous professional breastfeeding support during the early postpartum period is critically important, particularly for mothers who deliver via cesarean section.\n\nBreastfeeding self-efficacy, based on Bandura's Social Cognitive Theory, refers to a mother's belief in her ability to successfully perform and sustain breastfeeding. Higher breastfeeding self-efficacy has been associated with longer breastfeeding duration, more effective coping with breastfeeding difficulties, and stronger mother-infant bonding. In addition, oxytocin released during breastfeeding supports both milk ejection and emotional attachment, reinforcing the psychobiological relationship between effective breastfeeding and bonding processes.\n\nThis experimental study is designed as a pretest-posttest control group trial to evaluate the effectiveness of a multi-component breastfeeding support program during the early postpartum period. The study will be conducted at the Obstetrics Service and Lactation Counseling Clinic of Sivas Cumhuriyet University Training and Research Hospital between February 20, 2026 and August 30, 2026.\n\nIntervention Process (Experimental Group)\n\nThe intervention consists of two structured phases:\n\n1. Early In-Hospital Support (First 48 Hours)\n\n Mothers in the experimental group will receive individualized breastfeeding education and hands-on guidance provided by the researcher. The intervention includes positioning techniques, effective latch support, milk expression methods, management of common breastfeeding problems, and strengthening of skin-to-skin contact and rooming-in practices. Breastfeeding behavior will be observed and supported regularly during the first 48 hours postpartum.\n\n To enhance accessibility to educational content, QR code-supported digital materials will be provided. This will allow mothers to review educational materials when needed.\n\n Additionally, to increase breastfeeding motivation and encourage breastfeeding in social settings, supportive gift packages will be prepared. These packages will include a breastfeeding cover and convey the message that mothers can breastfeed their babies confidently in any environment. This approach aims to strengthen maternal confidence in breastfeeding outside the home.\n2. Post-Discharge Follow-Up (First 4 Weeks)\n\nAfter discharge, mothers in the experimental group will receive structured daily supportive and motivational text messages for 28 days. These messages are developed in accordance with current evidence-based breastfeeding and postpartum care guidelines and address breastfeeding management, milk physiology, maternal self-efficacy, bonding, and psychosocial well-being.\n\nIn addition, individualized telephone counseling sessions will be conducted on postpartum day 15 and at the end of the first month. These calls aim to assess breastfeeding progress, provide personalized problem-solving support, and reinforce maternal breastfeeding confidence.\n\nControl Group\n\nMothers in the control group will continue to receive routine postpartum care and standard breastfeeding counseling provided by the hospital. No additional intervention, motivational messaging, structured education program, or supportive materials will be provided to the control group.\n\nOutcome Measures\n\nThe primary outcome measures are the changes in breastfeeding self-efficacy and mother-infant bonding scores between baseline and the fourth postpartum week.\n\nIn addition, early postpartum breastfeeding effectiveness will be evaluated.\n\nStatistical analyses will be performed using SPSS software. Parametric or non-parametric tests will be applied according to data distribution characteristics. Effect sizes will be calculated and reported to determine the magnitude of the intervention effect.\n\nThis study aims to provide evidence on the effectiveness of structured and tele-support-enhanced breastfeeding programs for mothers who undergo cesarean delivery and to contribute to the development of sustainable postpartum breastfeeding support models."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only primiparous women who have undergone cesarean section delivery will be included in the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Primiparous mothers who have completed pregnancy\n\nMothers who delivered by cesarean section (C/S)\n\nMothers in the early postpartum period\n\nMothers aged 18 years and older\n\nMothers who are exclusively breastfeeding\n\nMothers with healthy and stable infants\n\nMothers with no medical conditions that may interfere with breastfeeding\n\nMothers who can read and understand Turkish and complete the data forms\n\nExclusion Criteria:\n\n* Mothers who experienced postpartum complications\n\nInfants with severe health problems, congenital anomalies, or requiring intensive care\n\nInfants hospitalized in neonatal intensive care unit\n\nMothers with medical or psychiatric conditions that prevent breastfeeding\n\nMothers with multiple pregnancies (twins, triplets, etc.)\n\nMothers who cannot attend follow-up visits during the study\n\nMothers without mobile phones\n\nMothers who received breastfeeding education during pregnancy'}, 'identificationModule': {'nctId': 'NCT07474402', 'briefTitle': 'The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section', 'orgStudyIdInfo': {'id': 'Sivas Cumhuriyet Univercity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group - Breastfeeding Support Program', 'description': "Participants will be randomly assigned to two groups. The intervention group will receive a multi-component breastfeeding support program including breastfeeding education, counseling, practical breastfeeding support, follow-up support, motivational messages for 28 days, individualized counseling according to participants' needs, telephone follow-up on day 15, and final evaluation via telephone at the end of the month. Participants will also receive a gift package containing a breastfeeding apron with a QR code providing access to a breastfeeding education video, aiming to increase breastfeeding confidence and promote breastfeeding behavior.", 'interventionNames': ['Behavioral: Breastfeeding Support Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group - Routine Postpartum Care', 'description': 'Control Group - Routine Postpartum Care:\n\nParticipants in the control group will receive routine postpartum care provided by the hospital. No additional breastfeeding support intervention will be applied to this group.'}], 'interventions': [{'name': 'Breastfeeding Support Program', 'type': 'BEHAVIORAL', 'description': 'In my thesis, the multi-component breastfeeding support program was applied to address a gap in the literature. Altay and Sarıalioğlu (2024, Breastfeeding Medicine, 19(12):947-956) showed that baby soothing training for primiparous mothers significantly improved maternal role perception, attachment, and breastfeeding self-efficacy (p\\<0.001). However, experimental studies simultaneously evaluating breastfeeding education, psychosocial support, video, message, telephone follow-ups, and individualized counseling are limited. Therefore, my study provides strong causal evidence using an experimental design. The sample size (n=100) is larger than many existing studies, and the study uniquely combines three measures: self-efficacy, bonding, and LATCH.', 'armGroupLabels': ['Intervention Group - Breastfeeding Support Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58030', 'city': 'Sivas', 'state': 'Merkez', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Shabnam Behnam Makouei, master', 'role': 'CONTACT', 'email': 'nlfrtugut@gmail.com', 'phone': '+90 552 828 5168'}, {'name': 'Prof. Dr. Nilüfer Tuğut, PhD', 'role': 'CONTACT', 'email': 'nlfrtugut@gmail.com', 'phone': '+90 532 775 48 28'}, {'name': 'shabnam behnam makouei, MSc (Master of Science)', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nilüfer Tuğut, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sivas Cumhuriyet University Hospital', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'centralContacts': [{'name': "shabnam Behnam Makouei, Master's Student", 'role': 'CONTACT', 'email': 'shabnambehnam.bm@gmail.com', 'phone': '+90 552 828 5168'}, {'name': 'Prof. Dr. Nilüfer Tuğut, PhD', 'role': 'CONTACT', 'email': 'nlfrtugut@gmail.com', 'phone': '+90 532 775 48 28'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicaltrials.gov/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be collected from February 20, 2026, to August 30, 2026. Individual participant data and supporting documents will be available after publication of the study results for 5 years.', 'ipdSharing': 'YES', 'description': 'The study protocol, statistical analysis plan, and SPSS datasets may be shared upon reasonable request while ensuring the protection of participant confidentiality and personal identifying information.', 'accessCriteria': 'Access to individual participant data and supporting documents will be available to qualified researchers, subject to approval of a data access request. Researchers may access de-identified datasets for scientific purposes after providing a research proposal and agreeing to data sharing and confidentiality conditions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Nursing Master's Student", 'investigatorFullName': 'Shabnam Behnam Makouei', 'investigatorAffiliation': 'Cumhuriyet University'}}}}