Breastfeeding Self-EfficacyNCT07474402
The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section
A study testing Breastfeeding Support Program in people with Breastfeeding Self-Efficacy and Mother-Infant Attachment, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Self-Efficacy, Mother-Infant Attachment, Breastfeeding Consultancy Training
- What is being tested?
- Breastfeeding Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University Hospital
Sivas, Merkez, 58030
Shabnam Behnam Makouei, master, +90 552 828 5168, nlfrtugut@gmail.com
Prof. Dr. Nilüfer Tuğut, PhD, +90 532 775 48 28, nlfrtugut@gmail.com
About this study
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:
- 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.
- Conditions
- Breastfeeding Self-Efficacy, Mother-Infant Attachment, Breastfeeding Consultancy Training, Primigravida Women
- Being tested
- Breastfeeding Support Program
- Keywords
- Cesarean Section, Breastfeeding Self-Efficacy, Maternal-Infant Bonding, Breastfeeding Support, Postpartum Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Support ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Breastfeeding Support Program | Experimental | 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. Receives: Behavioral: Breastfeeding Support Program |
| Control Group - Routine Postpartum Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 weeks postpartum follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start20 Feb 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding Self-EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shabnam Behnam Makouei, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474402
- Sponsor's protocol ID
- Sivas Cumhuriyet Univercity
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section
- ClinicalTrials.gov ID
- NCT07474402
- Acronym / sponsor ID
- Sivas Cumhuriyet Univercity
- Conditions
- Breastfeeding Self-Efficacy, Mother-Infant Attachment, Breastfeeding Consultancy Training, Primigravida Women
- Keywords
- Cesarean Section, Breastfeeding Self-Efficacy, Maternal-Infant Bonding, Breastfeeding Support, Postpartum Period
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Breastfeeding Support Program | Experimental | Behavioral: Breastfeeding Support ProgramParticipants 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. |
| Control Group - Routine Postpartum Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding Support ProgramIn 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. | Behavioural | Intervention Group - Breastfeeding Support Program |
Primary outcome
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.
1 secondary outcome
Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale
Time frame: 4 weeks postpartum follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 37635599Uzunkaya-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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Support Program in people with Breastfeeding Self-Efficacy and Mother-Infant Attachment, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shabnam Behnam Makouei, Master's Student (+90 552 828 5168, shabnambehnam.bm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale (time frame: Baseline (48 hours postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.