Effectiveness of Breastfeeding Education Using a Lactation Simulation Model Among Nursing Students: A Randomized Controlled Trial

NCT07720076 | Completed

• 1 other identifier: IKCU-SAEK-0143-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Breastfeeding education provided by nurses is an important determinant of breastfeeding success and maternal breastfeeding self-efficacy. Nursing students should acquire effective breastfeeding counseling skills before entering clinical practice. Simulation-based education offers students the opportunity to develop communication and clinical skills in a safe learning environment. The aim of this randomized controlled trial was to evaluate the effectiveness of breastfeeding education using a lactation simulation model among fourth-year nursing students. Students were randomly assigned to either an intervention group receiving simulation-based breastfeeding education using a lactation simulation model or a control group receiving routine theoretical breastfeeding education. During their maternity clinical placement, students provided standardized breastfeeding education to postpartum mothers. The primary outcomes were students' breastfeeding education skills and maternal breastfeeding self-efficacy. Secondary outcomes included breastfeeding success assessed by the LATCH Breastfeeding Assessment Tool and students' educational satisfaction. The findings of this study are expected to provide evidence supporting the integration of simulation-based breastfeeding education into undergraduate nursing curricula.

Conditions

Breastfeeding; Nursing Education; Breastfeeding Education

Keywords

Breastfeeding; Breastfeeding Education; Lactation Simulation Model; Simulation-Based Education; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Breastfeeding Education Skills of Nursing Students

  Nursing students' breastfeeding education skills assessed using the Breastfeeding Education Evaluation Form after completion of the educational intervention and during clinical practice.

  During the maternity clinical placement (up to 4 weeks after the educational intervention)

• Maternal Breastfeeding Self-Efficacy

  Maternal breastfeeding self-efficacy assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) after receiving breastfeeding education from nursing students.

  Before hospital discharge (within 48-72 hours postpartum)

Secondary Outcomes (2)

• Breastfeeding Success

  Before hospital discharge (within 48-72 hours postpartum)

• Student Educational Satisfaction

  Immediately after completion of the educational intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Nursing students assigned to the intervention group will receive breastfeeding education supported by a lactation model in addition to the standard breastfeeding course content. The training will include theoretical information and practical skills training using a lactation simulation model before clinical practice. Students will provide breastfeeding education to postpartum mothers during their clinical placement.

Behavioral: Lactation Simulation Model-Based Breastfeeding Education

Control Group

NO INTERVENTION

Nursing students assigned to the control group will receive standard breastfeeding education provided within the undergraduate nursing curriculum. Students will not receive additional training with a lactation model before clinical practice. They will provide breastfeeding education to postpartum mothers during their clinical placement according to the standard curriculum.

Interventions

Lactation Simulation Model-Based Breastfeeding Education BEHAVIORAL

The intervention consists of breastfeeding education provided to nursing students using a lactation simulation model. The training includes theoretical information and practical skills training before clinical practice. Students will practice breastfeeding support skills using the lactation model and subsequently provide breastfeeding education to postpartum mothers.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nursing Students:
• Fourth-year undergraduate nursing students enrolled in the Department of Nursing at Izmir Katip Celebi University.
• Students undertaking their maternity nursing clinical placement during the study period.
• Students who voluntarily agreed to participate and provided written informed consent.
• Postpartum Mothers:
• Mothers hospitalized in the postpartum unit of Izmir Ataturk Training and Research Hospital.
• Mothers aged 18 years or older.
• Mothers who delivered a healthy singleton infant.
• Mothers who were breastfeeding their infants.
• Mothers who were able to communicate in Turkish.
• Mothers who voluntarily agreed to participate and provided written informed consent.

You may not qualify if:

• Nursing Students:
• Students who did not complete the educational intervention or clinical placement.
• Students who withdrew from the study or had excessive absenteeism during the clinical placement.
• Postpartum Mothers:
• Mothers with medical conditions contraindicating breastfeeding.
• Infants with congenital anomalies or medical conditions preventing breastfeeding.
• Mothers whose infants required admission to the neonatal intensive care unit.
• Mothers who declined participation or withdrew consent.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İzmir Atatürk Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Researcher

Model Details: Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group using a computer-generated randomization sequence. The intervention group received simulation-based breastfeeding education using a lactation simulation model in addition to routine theoretical education, whereas the control group received routine theoretical breastfeeding education only. Both groups completed their maternity clinical placement under the same conditions.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: April 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)