- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06897397
Determination of the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-Efficacy
This study was planned to examine the effects of case management-based electronic fetal monitoring (EFM) training on midwifery students' EFM monitoring self-efficacy.
The research population will consist of second-year students studying at the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBÜ) in the spring semester of the 2023-2024 academic year (N: 80).
In this semi-experimental pre-test and post-test design and control group study, in order to determine the sample size; the data were normally distributed, the standard deviation of the main mass was estimated as 1 and the effect size (effect size, difference) was estimated as 0.8. For the analysis to be conducted, it was calculated that the highest power value of the study would be 0.942182 if two independent n₁=40, n₂=40 samples were taken at a significance level of 5%. The G-power analysis result is given below.
The students who volunteer to participate in the study will be assigned to the intervention and control groups with the computer-aided simple random sampling method. Computer-aided randomization will be used in the study, and the number of cases will be entered through the program with the URL address https://www.randomizer.org and random assignment will be made to the intervention and control groups. The study will be conducted single-blind. Before the application, all groups will be given 4 hours of theoretical information about EFM interpretation with a power point presentation. After the information, the "Electronic Fetal Monitoring Self-Efficacy Scale" will be applied as a pre-test. After the training, all students will be applied the "Electronic Fetal Monitoring Self-Efficacy Scale".
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a volunteer to participate in the research.
- Being an active student in the 2nd year of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences.
Exclusion Criteria:
- Being a passive student in the 2nd year of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group (n:40)
Students will be provided with information about the education plan flow chart, education plan content, and environment.
40 students assigned to the intervention group will be provided with information about EFM training based on the case method.
Before the application, all groups will be provided with 4 hours of theoretical information about EFM interpretation via a power point presentation.
|
Students will be provided with information about the education plan flow chart, education plan content, and environment.
40 students assigned to the intervention group will be provided with information about EFM training based on the case method.
Before the application, all groups will be provided with 4 hours of theoretical information about EFM interpretation via a power point presentation.
|
|
No Intervention: Control group (n:40
Control group students will receive 4 hours of theoretical training.
The training will be held in the midwifery department lecture hall.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Introductory Information Form
Time Frame: 10 minutes
|
This form, created by researchers based on literature, includes questions about the participants' age, high school graduation, case-based education status, etc.
|
10 minutes
|
|
Electronic Fetal Monitoring Self-Efficacy Scale
Time Frame: 10 minutes
|
It is a scale that can be applied to health professionals and students in the health field.
It is a 4-point Likert-type scale with 32 items, each item ranging from "Very confident" to "Not confident".
Each item includes direct expressions and is calculated as Very confident = 4 points, Confident = 3 points, Somewhat confident = 2 points and Not confident = 1 point.
A general score is obtained from the sum of all items.
A high score indicates that EFM monitoring self-efficacy is high.
The lowest score to be obtained from the scale varies between 32 and 128.
The scale does not have a cut-off score.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Introductory Information Form
Time Frame: 10 minutes
|
This form, created by researchers based on literature, includes questions about the participants' age, high school graduation, case-based education status, etc.
|
10 minutes
|
|
Electronic Fetal Monitoring Self-Efficacy Scale
Time Frame: 10 minutes
|
It is a scale that can be applied to health professionals and students in the health field.
It is a 4-point Likert-type scale with 32 items, each item ranging from "Very confident" to "Not confident".
Each item includes direct expressions and is calculated as Very confident = 4 points, Confident = 3 points, Somewhat confident = 2 points and Not confident = 1 point.
A general score is obtained from the sum of all items.
A high score indicates that EFM monitoring self-efficacy is high.
The lowest score to be obtained from the scale varies between 32 and 128.
The scale does not have a cut-off score.
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- SBU-AYDINKARTAL-010
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
product manufactured in and exported from the U.S.
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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