The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section

March 21, 2026 updated by: Shabnam Behnam Makouei, Cumhuriyet University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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.

  2. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Prof. Dr. Nilüfer Tuğut, PhD
  • Phone Number: +90 532 775 48 28
  • Email: nlfrtugut@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Sivas, Merkez, Turkey (Türkiye), 58030
        • Recruiting
        • Sivas Cumhuriyet University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • shabnam behnam makouei, MSc (Master of Science)
        • Principal Investigator:
          • Nilüfer Tuğut, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Breastfeeding Support Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cumhuriyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sivas Cumhuriyet Univercity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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