- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07720076
Effectiveness of Breastfeeding Education Using a Lactation Simulation Model Among Nursing Students: A Randomized Controlled Trial (LSM-BE)
The Effectiveness of Breastfeeding Education Using a Lactation Simulation Model on Nursing Students' Breastfeeding Education Skills, Mothers' Breastfeeding Self-Efficacy, Breastfeeding Success, and Student Satisfaction: A Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Breastfeeding is recognized as the optimal method of infant feeding and is associated with significant short- and long-term health benefits for both mothers and infants. International organizations recommend exclusive breastfeeding during the first six months of life and continued breastfeeding with appropriate complementary feeding thereafter. Effective breastfeeding counseling provided by healthcare professionals is essential for improving breastfeeding outcomes.
Nursing students frequently encounter breastfeeding mothers during maternity clinical placements; however, many students report insufficient confidence and practical competence in breastfeeding counseling. Simulation-based education has emerged as an effective educational strategy that enables students to practice clinical procedures, communication skills, and patient education in a realistic but safe learning environment before interacting with actual patients.
This randomized controlled trial evaluated the effectiveness of a lactation simulation model on nursing students' breastfeeding education competencies and maternal breastfeeding outcomes. Fourth-year nursing students enrolled in the Department of Nursing at Izmir Katip Celebi University were randomly allocated to intervention and control groups using a computer-generated randomization sequence.
All participants received routine theoretical breastfeeding education as part of the undergraduate nursing curriculum. Students allocated to the intervention group additionally received simulation-based breastfeeding education using a lactation simulation model in the Women's Health Nursing Skills Laboratory before beginning their maternity clinical placement. The simulation sessions focused on breastfeeding techniques, positioning, latch assessment, management of common breastfeeding problems, effective communication, and breastfeeding counseling.
Following completion of the educational intervention, students provided standardized breastfeeding education to postpartum mothers hospitalized in the postpartum unit of Izmir Ataturk Training and Research Hospital. Maternal breastfeeding self-efficacy was evaluated using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), breastfeeding success was assessed using the LATCH Breastfeeding Assessment Tool, students' educational performance was evaluated using a Breastfeeding Education Evaluation Form, and educational satisfaction was assessed using the Adult Education Satisfaction Scale.
The study aimed to determine whether simulation-based breastfeeding education improved nursing students' educational competencies and contributed to better maternal breastfeeding outcomes compared with routine theoretical education alone.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Izmir, Turkey (Türkiye)
- İzmir Atatürk Training and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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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.
Exclusion Criteria:
-
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
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.
|
|
No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Education Skills of Nursing Students
Time Frame: During the maternity clinical placement (up to 4 weeks after the educational intervention)
|
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)
|
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Maternal Breastfeeding Self-Efficacy
Time Frame: Before hospital discharge (within 48-72 hours postpartum)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Success
Time Frame: Before hospital discharge (within 48-72 hours postpartum)
|
Breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool.
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Before hospital discharge (within 48-72 hours postpartum)
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|
Student Educational Satisfaction
Time Frame: Immediately after completion of the educational intervention
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Students' satisfaction with the simulation-based educational program assessed using the Adult Education Satisfaction Scale.
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Immediately after completion of the educational intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKCU-SAEK-0143-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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