- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06458283
Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon
Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon Of Mıdwıfery Students
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Üsküdar
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Istanbul, Üsküdar, Turkey, 34668
- Sağlık Bilimleri Üniversitesi Hamidiye
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group
Investigation of the effectiveness of scenario-based standardized patient simulation training and breastfeeding management of midwifery students
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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.
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Experimental: Control Group
Standard training of midwifery students with low fidelty breast model
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low fidelity simulator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-EffectivenessEfficacy Scale
Time Frame: immediately before simulation
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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.
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immediately before simulation
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Self-EffectivenessEfficacy Scale
Time Frame: immediately after the simulation application
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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.
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immediately after the simulation application
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Self-EffectivenessEfficacy Scale
Time Frame: 4 weeks after the first simulation application
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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.
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4 weeks after the first simulation application
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Introductory Information Form
Time Frame: immediately before simulation
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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.
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immediately before simulation
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Student Satisfaction and Self-Confidence Scale in Learning
Time Frame: immediately after the simulation application
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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.
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immediately after the simulation application
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Simulation-Based Learning Assessment Scale
Time Frame: immediately after the simulation application
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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
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immediately after the simulation application
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Time Frame: immediately before simulation
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Form of 40 items: 1 Inadequate (0 points 2. Partially Satisfactory/Needs improvement (1 point): 3. Satisfactory (2 points)
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immediately before simulation
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BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Time Frame: 4 weeks after the first simulation application
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Form of 40 items: 1 Inadequate (0 points 2. Partially Satisfactory/Needs improvement (1 point): 3. Satisfactory (2 points)
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4 weeks after the first simulation application
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: yasemin aydın kartal, Assoc. Prof, Saglik Bilimleri Universitesi
- Principal Investigator: Ebru ÇALIŞKAN, PhD.Stu., Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAP2023/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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