- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06116448
Nursing Students& Breastfeeding Education& Simulation
October 30, 2023 updated by: sümeyye bakır, Ege University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İzmir, Turkey, 35040
- Sümeyye Bakır
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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
Exclusion Criteria:
During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: high-fidelity simulation
These students participated in a breastfeeding management scenario with a high-fidelity simulation mannikin named Noella S554.100 (n=11).
|
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.
|
|
Experimental: hybrid simulation
These students participated in the same breastfeeding management scenario with a standardized patient (n=11).
|
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.
|
|
Experimental: telesimulation
These students participated in the same breastfeeding management scenario with a standardized patient via Microsoft Teams video conferencing.
(n=11)
|
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.
|
|
No Intervention: control
The students in this group were the control group, and no intervention was made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
change from before implemention and 5th week of after practice
|
|
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.
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through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks
|
|
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.
|
change from before implemention and 5th week of after practice
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
students' self-confidence and satisfaction
Time Frame: through simulation practices completion, an average of 5 weeks
|
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.
|
through simulation practices completion, an average of 5 weeks
|
|
self-evaluation
Time Frame: through simulation practices completion, an average of 5 weeks
|
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.
|
through simulation practices completion, an average of 5 weeks
|
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education methods satisfaction
Time Frame: through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks
|
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.
|
through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: sümeyye bakır, master, Ege University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Toruner 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.
- Moloney 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2022
Primary Completion (Actual)
November 28, 2022
Study Completion (Actual)
January 11, 2023
Study Registration Dates
First Submitted
October 23, 2023
First Submitted That Met QC Criteria
October 30, 2023
First Posted (Estimated)
November 3, 2023
Study Record Updates
Last Update Posted (Estimated)
November 3, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- E.496527
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The researchers intend to publish the study as an article
IPD Sharing Time Frame
from January 2025
IPD Sharing Access Criteria
the article is planned to be published as open access
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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