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RecruitingNCT07474402Updated Mar 25, 2026

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

An interventional study of Breastfeeding Support Program in Breastfeeding Self-Efficacy, Mother-Infant Attachment and Breastfeeding Consultancy Training, sponsored by Cumhuriyet University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Cumhuriyet University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Breastfeeding Self-Efficacy
  • Mother-Infant Attachment
  • Breastfeeding Consultancy Training
  • Primigravida Women

Keywords

  • Cesarean Section
  • Breastfeeding Self-Efficacy
  • Maternal-Infant Bonding
  • Breastfeeding Support
  • Postpartum Period
03

In context

Lead sponsor

Cumhuriyet University is the lead sponsor of 128 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralBreastfeeding 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.

06

What researchers measure

Primary outcomes

  1. Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale

    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.

    Time frame: Baseline (48 hours postpartum)

Secondary outcomes

  1. Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale

    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

    Time frame: 4 weeks postpartum follow-up

07

Study locations

1 of 1 sites recruiting
  • Sivas Cumhuriyet University Hospital
    Sivas, Merkez 58030, Turkey (Türkiye)
    • Shabnam Behnam Makouei, master · Contact · nlfrtugut@gmail.com · +90 552 828 5168
    • Prof. Dr. Nilüfer Tuğut, PhD · Contact · nlfrtugut@gmail.com · +90 532 775 48 28
    • shabnam behnam makouei, MSc (Master of Science) · Principal investigator
    • Nilüfer Tuğut, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 37635599 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07474402
Lead sponsor
Cumhuriyet University
Responsible party
Shabnam Behnam Makouei (Nursing Master's Student, Cumhuriyet University) — Principal investigator
First posted
Mar 16, 2026
Start date
Feb 20, 2026
Primary completion
Aug 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Mar 25, 2026

Study contacts

shabnam Behnam Makouei, Master's Student
Contact
shabnambehnam.bm@gmail.com
+90 552 828 5168
Prof. Dr. Nilüfer Tuğut, PhD
Contact
nlfrtugut@gmail.com
+90 532 775 48 28

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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