Use of Different Simulation Techniques in Breastfeeding EducationNCT06643546
Effects of Simulation Practices on Breastfeeding Knowledge and Skills of Nursing Students
A study testing theoretical training, model simulation training and live-simulation in people with Use of Different Simulation Techniques in Breastfeeding Education, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study evaluated the effectiveness of breastfeeding education using different simulation techniques on nursing students' breastfeeding knowledge, counseling skills, and clinical self-efficacy. Method: The study sample consisted of 157 nursing students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Use of Different Simulation Techniques in Breastfeeding Education
- What is being tested?
- theoretical training, model simulation training and live-simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Nov 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- having taken a gynecology and obstetrics nursing course, volunteering to participate in the research, and not having received formal training on breastfeeding.
Who cannot join
- voluntarily withdrawing from the research and not participating in any stages of the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Simulation Applications Used in Breastfeeding Education on Breastfeeding Knowledge, Skills and Clinical Self-Efficacy of Nursing Students: A Randomized Controlled Trial
Objective: This study evaluated the effectiveness of breastfeeding education using different simulation techniques on nursing students' breastfeeding knowledge, counseling skills, and clinical self-efficacy.
Method: The study sample consisted of 157 nursing students. Data were collected using a sociodemographic questionnaire, the Breastfeeding Assistance Clinical Preparedness Scale, the Breastfeeding Knowledge Form, the Clinical Self-Efficacy in Performance Scale, and the Breastfeeding Counseling Skills Checklist.
Conclusion: We expect that simulation and standardized patient-based breastfeeding education will effectively improve nursing students' readiness for breastfeeding assistance, breastfeeding knowledge, breastfeeding counseling skills, and clinical self-efficacy in breastfeeding performance.
- Being tested
- theoretical training, model simulation training, live-simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theoretical trainingOther
received only theoretical breastfeeding training
model simulation trainingOther
theoretical breastfeeding training and model simulation training accompanied by scenarios
live-simulationOther
theoretical breastfeeding training and live simulation training with scenarios
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | received only theoretical breastfeeding training Receives: Other: theoretical training |
| 1st intervention group | Experimental | theoretical breastfeeding training and model simulation training accompanied by scenarios Receives: Other: model simulation training |
| 2nd intervention group | Experimental | theoretical breastfeeding training and live simulation training with scenarios Receives: Other: live-simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Assistance Clinical Readiness Scale
In the scale developed by the researchers, students evaluate themselves from 0 (not sure) to 10 (absolutely sure) based on the statement "I am ready to provide breastfeeding counseling and breastfeeding care to a mother who has given birth in the clinic.
Measured: before training, 1 hour after training, 4 weeks after
Breastfeeding Information Form
The Breastfeeding Information Form was prepared by researchers using the breastfeeding information inventory developed by Marzalik in 2004 and the competency verification toolkit guide published by the World Health Organization to ensure the competency of direct care providers in the implementation of the baby-friendly hospital initiative. The form consists of 25 statements. Participants are asked to answer each statement as true, false, and I don't know. A correct answer in the form is worth 1 point, and the highest score on the form is 25 and the lowest is 0. As the score received from the form increases, it is interpreted as the level of breastfeeding knowledge increases. In order to evaluate the appropriateness of the scope and content of the form, expert opinions will be obtained from at least 9 faculty members.
Measured: before training, 1 hour after training, 4 weeks after
Self-efficacy scale in clinical performance
In order to determine the self-efficacy perceptions of nursing students about their clinical performance, the Clinical Performance Self-Efficacy Scale (CPSES) was developed by Cheraghi et al. (2009) in 2009. The Turkish validity and reliability studies of the scale were conducted by Zaybak (2016). The scale, which consists of a total of 37 items, consists of 4 factors (sub-dimensions) as "Data collection", "Diagnosis and planning", "Application" and "Evaluation". The scale's total and sub-dimension score averages are evaluated by taking the item score average. A high score average obtained from the scale indicates that self-efficacy in clinical performance is high. The total Cronbach alpha coefficient of the scale was found to be 0.98.
Measured: before training, 1 hour after training, 4 weeks after
Breastfeeding Counseling Skills List
Created by researchers using professional practice guides. This skill list is used by the student during breastfeeding counseling. Scoring is done based on whether the breastfeeding counseling student demonstrates the skill. There are 25 steps in the skill list. Correct application is evaluated as 2 points, incomplete application as 1 point, and failure to apply as 0 points. The maximum score received from the list is 50 and the minimum score is 0. Expert opinions will be obtained from at least 9 faculty members in order to evaluate the appropriateness of the scope and content of the form
Measured: 4 week after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jul 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Nov 2024 (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 Use of Different Simulation Techniques in Breastfeeding EducationStudies 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
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Ceylan, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643546
- Sponsor's protocol ID
- 2024/95
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceylan S, Pardes BB, Erdogan EN, Guvenc G, Kok G, Kurt G. The Effect of Different Simulation Approaches in Breastfeeding Education on Nursing Students' Knowledge, Skills, and Clinical Self-Efficacy: A Randomized Controlled Trial. Breastfeed Med. 2025 Dec;20(12):931-938. doi: 10.1177/15568253251382933. Epub 2025 Oct 6.
PubMed 41051939
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Simulation Applications Used in Breastfeeding Education on Breastfeeding Knowledge, Skills and Clinical Self-Efficacy of Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06643546
- Acronym / sponsor ID
- 2024/95
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 16 Oct 2024 (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.
Objective: This study evaluated the effectiveness of breastfeeding education using different simulation techniques on nursing students' breastfeeding knowledge, counseling skills, and clinical self-efficacy.
Method: The study sample consisted of 157 nursing students. Data were collected using a sociodemographic questionnaire, the Breastfeeding Assistance Clinical Preparedness Scale, the Breastfeeding Knowledge Form, the Clinical Self-Efficacy in Performance Scale, and the Breastfeeding Counseling Skills Checklist.
Conclusion: We expect that simulation and standardized patient-based breastfeeding education will effectively improve nursing students' readiness for breastfeeding assistance, breastfeeding knowledge, breastfeeding counseling skills, and clinical self-efficacy in breastfeeding performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Other: theoretical trainingreceived only theoretical breastfeeding training |
| 1st intervention group | Experimental | Other: model simulation trainingtheoretical breastfeeding training and model simulation training accompanied by scenarios |
| 2nd intervention group | Experimental | Other: live-simulationtheoretical breastfeeding training and live simulation training with scenarios |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- having taken a gynecology and obstetrics nursing course, volunteering to participate in the research, and not having received formal training on breastfeeding.
Key exclusion criteria (1 listed)
- voluntarily withdrawing from the research and not participating in any stages of the research.
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 |
|---|---|---|
| theoretical trainingreceived only theoretical breastfeeding training | Other | control |
| model simulation trainingtheoretical breastfeeding training and model simulation training accompanied by scenarios | Other | 1st intervention group |
| live-simulationtheoretical breastfeeding training and live simulation training with scenarios | Other | 2nd intervention group |
Primary outcome
Breastfeeding Assistance Clinical Readiness Scale
Time frame: before training, 1 hour after training, 4 weeks after
In the scale developed by the researchers, students evaluate themselves from 0 (not sure) to 10 (absolutely sure) based on the statement "I am ready to provide breastfeeding counseling and breastfeeding care to a mother who has given birth in the clinic.
Breastfeeding Information Form
Time frame: before training, 1 hour after training, 4 weeks after
The Breastfeeding Information Form was prepared by researchers using the breastfeeding information inventory developed by Marzalik in 2004 and the competency verification toolkit guide published by the World Health Organization to ensure the competency of direct care providers in the implementation of the baby-friendly hospital initiative. The form consists of 25 statements. Participants are asked to answer each statement as true, false, and I don't know. A correct answer in the form is worth 1 point, and the highest score on the form is 25 and the lowest is 0. As the score received from the form increases, it is interpreted as the level of breastfeeding knowledge increases. In order to evaluate the appropriateness of the scope and content of the form, expert opinions will be obtained from at least 9 faculty members.
Self-efficacy scale in clinical performance
Time frame: before training, 1 hour after training, 4 weeks after
In order to determine the self-efficacy perceptions of nursing students about their clinical performance, the Clinical Performance Self-Efficacy Scale (CPSES) was developed by Cheraghi et al. (2009) in 2009. The Turkish validity and reliability studies of the scale were conducted by Zaybak (2016). The scale, which consists of a total of 37 items, consists of 4 factors (sub-dimensions) as "Data collection", "Diagnosis and planning", "Application" and "Evaluation". The scale's total and sub-dimension score averages are evaluated by taking the item score average. A high score average obtained from the scale indicates that self-efficacy in clinical performance is high. The total Cronbach alpha coefficient of the scale was found to be 0.98.
Breastfeeding Counseling Skills List
Time frame: 4 week after training
Created by researchers using professional practice guides. This skill list is used by the student during breastfeeding counseling. Scoring is done based on whether the breastfeeding counseling student demonstrates the skill. There are 25 steps in the skill list. Correct application is evaluated as 2 points, incomplete application as 1 point, and failure to apply as 0 points. The maximum score received from the list is 50 and the minimum score is 0. Expert opinions will be obtained from at least 9 faculty members in order to evaluate the appropriateness of the scope and content of the form
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 41051939Ceylan S, Pardes BB, Erdogan EN, Guvenc G, Kok G, Kurt G. The Effect of Different Simulation Approaches in Breastfeeding Education on Nursing Students' Knowledge, Skills, and Clinical Self-Efficacy: A Randomized Controlled Trial. Breastfeed Med. 2025 Dec;20(12):931-938. doi: 10.1177/15568253251382933. Epub 2025 Oct 6.
- Individual participant dataSharing planned: No
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 theoretical training, model simulation training and live-simulation in people with Use of Different Simulation Techniques in Breastfeeding Education, run by Gulhane School of Medicine 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. 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?
Results are not available in the source record.
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 Assistance Clinical Readiness Scale (time frame: before training, 1 hour after training, 4 weeks after). The study lists 4 primary outcomes in all. 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 NCT06643546, 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 16 Oct 2024.