BreastfeedingLSM-BENCT07720076
Effectiveness of Breastfeeding Education Using a Lactation Simulation Model Among Nursing Students: A Randomized Controlled Trial
A study testing Lactation Simulation Model-Based Breastfeeding Education in people with Breastfeeding and Breastfeeding Education, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding Education, Nursing Education
- What is being tested?
- Lactation Simulation Model-Based Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- 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:
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- 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.
Who cannot join
- -
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Atatürk Training and Research Hospital
Izmir
About this study
Official title: 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.
Read the 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.
- Conditions
- Breastfeeding, Breastfeeding Education, Nursing Education
- Being tested
- Lactation Simulation Model-Based Breastfeeding Education
- Keywords
- Breastfeeding, Breastfeeding Education, Lactation Simulation Model, Simulation-Based Education, Randomized Controlled Trial
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactation Simulation Model-Based Breastfeeding EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before hospital discharge (within 48-72 hours postpartum)
Secondary outcomes (2)
Breastfeeding Success
Breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool.
Measured: Before hospital discharge (within 48-72 hours postpartum)
Student Educational Satisfaction
Students' satisfaction with the simulation-based educational program assessed using the Adult Education Satisfaction Scale.
Measured: Immediately after completion of the educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Apr 2025
- Primary completion30 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM CATAKOGLU, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720076
- Sponsor's protocol ID
- IKCU-SAEK-0143-2024
- Acronym
- LSM-BE
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07720076
- Acronym / sponsor ID
- LSM-BE / IKCU-SAEK-0143-2024
- Conditions
- Breastfeeding, Breastfeeding Education, Nursing Education
- Keywords
- Breastfeeding, Breastfeeding Education, Lactation Simulation Model, Simulation-Based Education, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Jul 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Lactation Simulation Model-Based Breastfeeding EducationNursing 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- 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.
- Mothers hospitalized in the postpartum unit of Izmir Ataturk Training and Research Hospital.
Key exclusion criteria (9 listed)
- -
- 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.
- Mothers with medical conditions contraindicating breastfeeding.
- Infants with congenital anomalies or medical conditions preventing breastfeeding.
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 |
|---|---|---|
| Lactation Simulation Model-Based Breastfeeding EducationThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
Maternal Breastfeeding Self-Efficacy
Time frame: Before hospital discharge (within 48-72 hours postpartum)
Maternal breastfeeding self-efficacy assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) after receiving breastfeeding education from nursing students.
2 secondary outcomes
Breastfeeding Success
Time frame: Before hospital discharge (within 48-72 hours postpartum)
Student Educational Satisfaction
Time frame: Immediately after completion of the educational intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactation Simulation Model-Based Breastfeeding Education in people with Breastfeeding and Breastfeeding Education, run by Izmir Katip Celebi 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 12 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Education Skills of Nursing Students (time frame: During the maternity clinical placement (up to 4 weeks after the educational intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.