- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474402
The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Breastfeeding 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.
This 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.
Intervention Process (Experimental Group)
The intervention consists of two structured phases:
Early In-Hospital Support (First 48 Hours)
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.
To enhance accessibility to educational content, QR code-supported digital materials will be provided. This will allow mothers to review educational materials when needed.
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.
- Post-Discharge Follow-Up (First 4 Weeks)
After 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.
In 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.
Control Group
Mothers 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.
Outcome Measures
The primary outcome measures are the changes in breastfeeding self-efficacy and mother-infant bonding scores between baseline and the fourth postpartum week.
In addition, early postpartum breastfeeding effectiveness will be evaluated.
Statistical 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.
This 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: shabnam Behnam Makouei, Master's Student
- Phone Number: +90 552 828 5168
- Email: shabnambehnam.bm@gmail.com
Study Contact Backup
- Name: Prof. Dr. Nilüfer Tuğut, PhD
- Phone Number: +90 532 775 48 28
- Email: nlfrtugut@gmail.com
Study Locations
-
-
Merkez
-
Sivas, Merkez, Turkey (Türkiye), 58030
- Recruiting
- Sivas Cumhuriyet University Hospital
-
Contact:
- Prof. Dr. Nilüfer Tuğut, PhD
- Phone Number: +90 532 775 48 28
- Email: nlfrtugut@gmail.com
-
Contact:
- Shabnam Behnam Makouei, master
- Phone Number: +90 552 828 5168
- Email: nlfrtugut@gmail.com
-
Principal Investigator:
- shabnam behnam makouei, MSc (Master of Science)
-
Principal Investigator:
- Nilüfer Tuğut, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primiparous mothers who have completed pregnancy
Mothers who delivered by cesarean section (C/S)
Mothers in the early postpartum period
Mothers aged 18 years and older
Mothers who are exclusively breastfeeding
Mothers with healthy and stable infants
Mothers with no medical conditions that may interfere with breastfeeding
Mothers who can read and understand Turkish and complete the data forms
Exclusion Criteria:
- Mothers who experienced postpartum complications
Infants with severe health problems, congenital anomalies, or requiring intensive care
Infants hospitalized in neonatal intensive care unit
Mothers with medical or psychiatric conditions that prevent breastfeeding
Mothers with multiple pregnancies (twins, triplets, etc.)
Mothers who cannot attend follow-up visits during the study
Mothers without mobile phones
Mothers who received breastfeeding education during pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group - Breastfeeding Support Program
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.
|
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.
|
|
No Intervention: Control Group - Routine Postpartum Care
Control Group - Routine Postpartum Care: Participants in the control group will receive routine postpartum care provided by the hospital. No additional breastfeeding support intervention will be applied to this group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale
Time Frame: Baseline (48 hours postpartum)
|
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.
|
Baseline (48 hours postpartum)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale
Time Frame: 4 weeks postpartum follow-up
|
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
|
4 weeks postpartum follow-up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sivas Cumhuriyet Univercity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primigravida Women
-
Alexandria UniversityRecruiting
-
Assiut UniversityNot yet recruitingCervical Length | Bishop Score | Primigravida Women
-
Kırklareli UniversityRecruitingQuality of Life | Anxiety | Music Therapy | Primigravida Women | Blood Pressure MonitoringTurkey
-
Federal Teaching Hospital AbakalikiCompletedLabour Duration | PrimigravidaNigeria
-
University of LeedsNational Institute of Academic Anaesthesia (NIAA), UK; Obstetric Anaethetists...UnknownPregnancy | Labour | Epidural Block | Primigravida LabourUnited Kingdom
-
Pravara Institute of Medical Sciences UniversityWithdrawnPrimigravida in Labour Pains
-
Riphah International UniversityCompletedDepression | Sleep Quality | Primigravida FemalesPakistan
-
National Institute of Neurosciences and Hospital...Directorate General of Health Services, BangladeshActive, not recruitingPregnant Women | Pregnant Women and Their OffspringBangladesh
-
Near East University, TurkeyCompletedHealthy Postmenopausal Women | Serum CNP Levels | Healthy Reproductive Age Women | Healthy Perimenopausal WomenCyprus
Clinical Trials on Breastfeeding Support Program
-
Pamukkale UniversityRecruitingBreastfeeding Self-Efficacy Attitude to Health Postpartum Period PrimiparityTurkey
-
Ozge KayaThe Scientific and Technological Research Council of TurkeyCompletedBreastfeeding SupportTurkey (Türkiye)
-
Sakarya UniversityRecruitingPaternal Involvement in Breastfeeding | Parental Support for BreastfeedingTurkey (Türkiye)
-
Sichuan UniversityCompletedBreast Feeding | Social Support | CoparentingChina
-
University of CopenhagenDanish Committee for Health Education; Nordea-fonden; Det Obelske Familiefond; 21...Active, not recruiting
-
University College, LondonCompletedStress, Psychological | Breastfeeding | Preterm Infant | Postnatal DepressionUnited Kingdom
-
University Hospital of SplitUnknown
-
Children's Hospital of Eastern OntarioThe Physicians' Services Incorporated FoundationCompleted
-
Agri Ibrahim Cecen UniversityCompleted
-
The Hong Kong Polytechnic UniversityCompletedParents | Breast Feeding, ExclusiveHong Kong