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:
Cumhuriyet University
Organization:
Study Overview
Official Title:
The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: