Effects of Simulation Practices on Breastfeeding Knowledge and Skills of Nursing Students

October 13, 2024 updated by: Sinem Ceylan, Gulhane School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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.
157

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
      • Ankara, Turkey
        • Gulhane Nursing Faculty

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

having taken a gynecology and obstetrics nursing course, volunteering to participate in the research, and not having received formal training on breastfeeding.

Exclusion Criteria:

voluntarily withdrawing from the research and not participating in any stages of the research.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: control
received only theoretical breastfeeding training
Other: theoretical training
received only theoretical breastfeeding training
Experimental: 1st intervention group
theoretical breastfeeding training and model simulation training accompanied by scenarios
Other: model simulation training
theoretical breastfeeding training and model simulation training accompanied by scenarios
Experimental: 2nd intervention group
theoretical breastfeeding training and live simulation training with scenarios
Other: live-simulation
theoretical breastfeeding training and live simulation training with scenarios

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 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.
before training, 1 hour after training, 4 weeks after
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.
before training, 1 hour after training, 4 weeks after
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.
before training, 1 hour after training, 4 weeks after
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
4 week after training

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.
Gulhane School of Medicine

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.
July 1, 2024

Primary Completion (Estimated)

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.
October 30, 2024

Study Completion (Estimated)

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.
November 30, 2024

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 10, 2024

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 13, 2024

First Posted (Actual)

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.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

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.
October 16, 2024

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 13, 2024

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, 2024

More Information

Terms related to this study

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.
  • 2024/95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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