Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon

September 18, 2024 updated by: Ebru Çalışkan, Saglik Bilimleri Universitesi

Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon Of Mıdwıfery Students

It was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences

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.

Detailed Description

This study was planned to determine the effect of hybrid simulation-based breastfeeding education on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences. The research, planned in a randomized controlled experimental design, will be conducted with Istanbul Health Sciences University Hamidiye Health Sciences Faculty midwifery 2nd year students (N: 84). Students participating in the study will be divided into intervention (n: 42) and control (n: 42) groups according to the computer-assisted simple random sampling technique. Both groups will be given 4 hours of theoretical information about breast milk and breastfeeding education before the application. 42 students assigned to the intervention group will receive training with a high-reality simulator fitted to a standard patient, accompanied by a scenario, and 42 students assigned to the control group will receive practice training with an adult standard patient care model. Introductory Information Form, Simulation-Based Learning Evaluation Scale, Student Satisfaction and Self-Confidence in Learning Scale, Self-Efficacy-Sufficiency Scale, Breastfeeding Management Skill Evaluation Form will be applied to the students participating in the research.

As a result of the findings, discussion and conclusions of the study will be written.

It is important to increase the competency level of midwifery students in breastfeeding management in a simulation environment that creates virtual reality, before the care applied on real patients in a clinical environment. It is recommended to integrate high-reality simulators and standard patient methods into the curriculum in the education of midwifery students . This study aims to increase the application skills, satisfaction, self-confidence and self-efficacy levels of midwifery department students with hybrid simulation-based Breastfeeding education, in which two or more simulation types (standard patient and Lactation Simulator) are combined to produce a more realistic simulation experience.

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 (Estimated)

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.
82

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
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34668
        • Sağlık Bilimleri Üniversitesi Hamidiye

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Having a statement of consent Being a second year midwifery student

Exclusion Criteria:

Wishing to withdraw from the research at any time. Not participating in all simulation applications Incompletely filling out data collection forms

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: Prevention
  • 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: Experimental Group
Investigation of the effectiveness of scenario-based standardized patient simulation training and breastfeeding management of midwifery students
Other: hiybrid simulation
The intervention group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by a high-reality simulator accompanied by a scenario, and the control group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by an adult standard patient care model.
Experimental: Control Group
Standard training of midwifery students with low fidelty breast model
Other: control grup
low fidelity simulator

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
Self-EffectivenessEfficacy Scale
Time Frame: immediately before simulation
TThe Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
immediately before simulation
Self-EffectivenessEfficacy Scale
Time Frame: immediately after the simulation application
The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
immediately after the simulation application
Self-EffectivenessEfficacy Scale
Time Frame: 4 weeks after the first simulation application
The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
4 weeks after the first simulation application
Introductory Information Form
Time Frame: immediately before simulation
In this form, which was created by the researchers based on the literature, the participants' age, the high school they graduated from, the education level of their parents, their willingness to choose the profession, their feeling of belonging to the profession, etc. questions are included. The Introductory Information Form is in a multiple-choice format consisting of 25 questions by scanning the literature by the researchers.
immediately before simulation
Student Satisfaction and Self-Confidence Scale in Learning
Time Frame: immediately after the simulation application
The scale is a 13-item measurement tool designed to measure student satisfaction with simulation and self-confidence during practices. It is a 5-point Likert type and is scored as strongly disagree 1, disagree 2, undecided 3, agree 4, strongly agree 5.According to the Turkish adaptation of the scale, the total number of items is 12. This scale measures student satisfaction and self-confidence regarding learning in a simulation environment. The scale consists of two subheadings: "Satisfaction with Current Learning" and "Self-Confidence in Learning." The subheading "Satisfaction with Current Learning" includes 5 items, and the subheading "Self-Confidence in Learning" includes 7 items, with no negatively coded items.
immediately after the simulation application
Simulation-Based Learning Assessment Scale
Time Frame: immediately after the simulation application
The scale has 5 sub-dimensions (nursing process, patient safety, professional information, communication and reflected behavior) and consists of 37 items.All statements on the scale are positive, and there are no negatively coded items. The scale evaluates the essential competencies that a nurse should possess, including the nursing process, patient safety, professional knowledge, communication, and reflective behavior concepts. An increase in the score obtained from the sub-dimensions of the scale indica
immediately after the simulation application

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
BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Time Frame: immediately before simulation
Form of 40 items: 1 Inadequate (0 points 2. Partially Satisfactory/Needs improvement (1 point): 3. Satisfactory (2 points)
immediately before simulation
BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Time Frame: 4 weeks after the first simulation application
Form of 40 items: 1 Inadequate (0 points 2. Partially Satisfactory/Needs improvement (1 point): 3. Satisfactory (2 points)
4 weeks after the first simulation application

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.
Saglik Bilimleri Universitesi

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.
  • Study Director: yasemin aydın kartal, Assoc. Prof, Saglik Bilimleri Universitesi
  • Principal Investigator: Ebru ÇALIŞKAN, PhD.Stu., Saglik Bilimleri Universitesi

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.
May 10, 2023

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.
May 10, 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 10, 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).
June 9, 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.
June 9, 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.
June 13, 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.
September 19, 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.
September 18, 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.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • BAP2023/18

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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