BreastfeedingNCT06116448
Nursing Students& Breastfeeding Education& Simulation
A study testing high-fidelity simulation, hybrid simulation and telesimulation in people with Breastfeeding, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to determine the effect of different simulation methods on nursing students' self-confidence, satisfaction, and clinical breastfeeding management knowledge and skills in managing and supporting breastfeeding in the early postpartum period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- high-fidelity simulation, hybrid simulation and telesimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2022to 11 Jan 2023
- 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
- The voluntarily agree to participate in the study Not having experience with simulation Being a 3rd year nursing undergraduate student not working as a nurse
Who cannot join
- During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Simulation-Based Education on Nursing Students' Breastfeeding Knowledge, Skills, Confidence, and Satisfaction.
The study aimed to determine the effect of different simulation methods on nursing students' self-confidence, satisfaction, and clinical breastfeeding management knowledge and skills in managing and supporting breastfeeding in the early postpartum period.
Read the detailed description
This study aimed to investigate the effectiveness of simulation-based training methods in improving the breastfeeding management knowledge and skills of third-year nursing students. The study utilized a quasi-experimental design with pre-test and post-test control groups. The results of the intervention groups that received high-fidelity, hybrid, and telesimulation training were compared with a control group that received traditional training. A clinical follow-up phase was conducted after the interventions to evaluate their impact. The study used various data collection tools to measure different factors, including knowledge and skills, confidence in learning, satisfaction, training satisfaction, and self-assessment of simulations.
- Conditions
- Breastfeeding
- Being tested
- high-fidelity simulation, hybrid simulation, telesimulation
- Keywords
- breastfeeding, nursing students, Nursing Research, Educational
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-fidelity simulationOther
The high-fidelity simulation involved a student and a computer-based mannikin. Prior to the start of the scenario, a pre-briefing session was provided. The scenario was executed with the help of the researcher from the control room. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices.
hybrid simulationOther
The hybrid simulation involved a student and a standardized patient. The patient wore a wearable breast model and held a model baby. Prior to the start of the scenario, a pre-briefing session was provided. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices.
telesimulationOther
The telesimulation involved a student and a standardized patient. The patient wore a wearable breast model and held a model baby. Students and patients communicated via video conferencing. Prior to the start of the scenario, a pre-briefing session was provided. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices.
| Study group | Role | What they receive |
|---|---|---|
| high-fidelity simulation | Experimental | These students participated in a breastfeeding management scenario with a high-fidelity simulation mannikin named Noella S554.100 (n=11). Receives: Other: high-fidelity simulation |
| hybrid simulation | Experimental | These students participated in the same breastfeeding management scenario with a standardized patient (n=11). Receives: Other: hybrid simulation |
| telesimulation | Experimental | These students participated in the same breastfeeding management scenario with a standardized patient via Microsoft Teams video conferencing. (n=11) Receives: Other: telesimulation |
| control | No intervention | The students in this group were the control group, and no intervention was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
breastfeeding management knowledge
The researchers developed a measurement tool to assess information. The tool uses a scoring system where correct statements receive one point and incorrect statements receive zero points. The total score ranges from 0 to 47 points.
Measured: change from before implemention and 5th week of after practice
breastfeeding management skills
The researchers developed a checklist to assess skills. The tool uses a scoring system where correct practice receives one point and incorrect statements receive zero points. The checklist consists of seven sections. The number of items in each section ranges from 4 to 14.
Measured: through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks
Evaluation of Breastfeeding Education
The researchers developed a measurement tool to assess breastfeeding education. The form items are evaluated as feeling adequate or inadequate (1 or 0 points). The total score ranges from 0 to 27 points.
Measured: change from before implemention and 5th week of after practice
Secondary outcomes (3)
students' self-confidence and satisfaction
It is a scale published by the National League for Nurses (NLN) to measure students' attitudes and beliefs about simulation.The highest score that can be obtained from the scale is 65 and the lowest score is 13.
Measured: through simulation practices completion, an average of 5 weeks
self-evaluation
The self-report scale assesses the impact of simulation lab practices on nursing students' professional knowledge, skills, and attitudes.The lowest score that can be obtained from the scale is 0 and the highest score is 92.
Measured: through simulation practices completion, an average of 5 weeks
education methods satisfaction
It evaluates the degree of contentment of the student with the teaching methodology implemented.In evaluating the satisfaction with training methods, students are scored from 20 to 80.
Measured: through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start4 Nov 2022
- Primary completion28 Nov 2022
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, parallel, randomized, controlled quasi-experiment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sümeyye bakır, Ege University
- Investigators
- sümeyye bakır, master, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116448
- Sponsor's protocol ID
- E.496527
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers intend to publish the study as an article
Publications
Sittner BJ, Aebersold ML, Paige JB, Graham LL, Schram AP, Decker SI, Lioce L. INACSL Standards of Best Practice for Simulation: Past, Present, and Future. Nurs Educ Perspect. 2015 Sep-Oct;36(5):294-8. doi: 10.5480/15-1670.
PubMed 26521497Toruner EK, Altay N, Arpaci T, Sari Ozturk C, Ceylan C, Yildiz S, Cakir G. The development of a self-evaluation scale for simulation laboratory practices. Nurse Educ Today. 2021 Sep;104:104990. doi: 10.1016/j.nedt.2021.104990. Epub 2021 Jun 2.
PubMed 34146847Moloney M, Murphy L, Kingston L, Markey K, Hennessy T, Meskell P, Atkinson S, Doody O. Final year undergraduate nursing and midwifery students' perspectives on simulation-based education: a cross-sectional study. BMC Nurs. 2022 Nov 6;21(1):299. doi: 10.1186/s12912-022-01084-w.
PubMed 36335322
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Simulation-Based Education on Nursing Students' Breastfeeding Knowledge, Skills, Confidence, and Satisfaction.
- ClinicalTrials.gov ID
- NCT06116448
- Acronym / sponsor ID
- E.496527
- Conditions
- Breastfeeding
- Keywords
- breastfeeding, nursing students, Nursing Research, Educational
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 3 Nov 2023 (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.
The study aimed to determine the effect of different simulation methods on nursing students' self-confidence, satisfaction, and clinical breastfeeding management knowledge and skills in managing and supporting breastfeeding in the early postpartum period.
Detailed description
This study aimed to investigate the effectiveness of simulation-based training methods in improving the breastfeeding management knowledge and skills of third-year nursing students. The study utilized a quasi-experimental design with pre-test and post-test control groups. The results of the intervention groups that received high-fidelity, hybrid, and telesimulation training were compared with a control group that received traditional training. A clinical follow-up phase was conducted after the interventions to evaluate their impact. The study used various data collection tools to measure different factors, including knowledge and skills, confidence in learning, satisfaction, training satisfaction, and self-assessment of simulations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- prospective, parallel, randomized, controlled quasi-experiment
| Arm | Type | Receives |
|---|---|---|
| high-fidelity simulation | Experimental | Other: high-fidelity simulationThese students participated in a breastfeeding management scenario with a high-fidelity simulation mannikin named Noella S554.100 (n=11). |
| hybrid simulation | Experimental | Other: hybrid simulationThese students participated in the same breastfeeding management scenario with a standardized patient (n=11). |
| telesimulation | Experimental | Other: telesimulationThese students participated in the same breastfeeding management scenario with a standardized patient via Microsoft Teams video conferencing. (n=11) |
| control | No intervention | –The students in this group were the control group, and no intervention was made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The voluntarily agree to participate in the study Not having experience with simulation Being a 3rd year nursing undergraduate student not working as a nurse
Key exclusion criteria (1 listed)
- During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
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 |
|---|---|---|
| high-fidelity simulationThe high-fidelity simulation involved a student and a computer-based mannikin. Prior to the start of the scenario, a pre-briefing session was provided. The scenario was executed with the help of the researcher from the control room. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices. | Other | high-fidelity simulation |
| hybrid simulationThe hybrid simulation involved a student and a standardized patient. The patient wore a wearable breast model and held a model baby. Prior to the start of the scenario, a pre-briefing session was provided. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices. | Other | hybrid simulation |
| telesimulationThe telesimulation involved a student and a standardized patient. The patient wore a wearable breast model and held a model baby. Students and patients communicated via video conferencing. Prior to the start of the scenario, a pre-briefing session was provided. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices. | Other | telesimulation |
Primary outcome
breastfeeding management knowledge
Time frame: change from before implemention and 5th week of after practice
The researchers developed a measurement tool to assess information. The tool uses a scoring system where correct statements receive one point and incorrect statements receive zero points. The total score ranges from 0 to 47 points.
breastfeeding management skills
Time frame: through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks
The researchers developed a checklist to assess skills. The tool uses a scoring system where correct practice receives one point and incorrect statements receive zero points. The checklist consists of seven sections. The number of items in each section ranges from 4 to 14.
Evaluation of Breastfeeding Education
Time frame: change from before implemention and 5th week of after practice
The researchers developed a measurement tool to assess breastfeeding education. The form items are evaluated as feeling adequate or inadequate (1 or 0 points). The total score ranges from 0 to 27 points.
3 secondary outcomes
students' self-confidence and satisfaction
Time frame: through simulation practices completion, an average of 5 weeks
self-evaluation
Time frame: through simulation practices completion, an average of 5 weeks
education methods satisfaction
Time frame: through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks
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 3 Nov 2023.
- Background: PubMed 26521497Sittner BJ, Aebersold ML, Paige JB, Graham LL, Schram AP, Decker SI, Lioce L. INACSL Standards of Best Practice for Simulation: Past, Present, and Future. Nurs Educ Perspect. 2015 Sep-Oct;36(5):294-8. doi: 10.5480/15-1670.
- Background: PubMed 34146847Toruner EK, Altay N, Arpaci T, Sari Ozturk C, Ceylan C, Yildiz S, Cakir G. The development of a self-evaluation scale for simulation laboratory practices. Nurse Educ Today. 2021 Sep;104:104990. doi: 10.1016/j.nedt.2021.104990. Epub 2021 Jun 2.
- Background: PubMed 36335322Moloney M, Murphy L, Kingston L, Markey K, Hennessy T, Meskell P, Atkinson S, Doody O. Final year undergraduate nursing and midwifery students' perspectives on simulation-based education: a cross-sectional study. BMC Nurs. 2022 Nov 6;21(1):299. doi: 10.1186/s12912-022-01084-w.
- Individual participant dataSharing planned: Yes. The researchers intend to publish the study as an article
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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.
sümeyye bakır, master principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-fidelity simulation, hybrid simulation and telesimulation in people with Breastfeeding, run by Ege 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 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: finished, as of the sponsor's last update on 3 Nov 2023. 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 management knowledge (time frame: change from before implemention and 5th week of after practice). The study lists 3 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 NCT06116448, which also lists 3 linked publications.
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 3 Nov 2023.