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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: high-fidelity simulation
These students participated in a breastfeeding management scenario with a high-fidelity simulation mannikin named Noella S554.100 (n=11).
Other: high-fidelity simulation
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).
Other: hybrid simulation
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)
Other: telesimulation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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