The Effect of Simulation-based Electronic Fetal Monitoring Training on Midwifery Students

The Effect of Simulation-Based Electronic Fetal Monitoring Training on Self-Efficacy-Efficacy and Anxiety Levels of Midwifery Students

This study was planned to determine the effect of scenario-based high-fidelity electronic fetal monitoring simulation method on midwifery students' self-efficacy-efficacy and situational anxiety levels. The study was planned as a randomized controlled experimental study. This RCT will be administered following the CONSORT 2010 guidelines. Midwifery students will be given information about the introduction of the simulator and the model, the flow chart of the training plan, the content of the training plan, the environment, the locations of the materials. 40 students selected for the intervention group will be given high-fidelity simulator and information on case-based learning will be given to 40 students selected for the training and control group. "State Anxiety Inventory" and "Self-Efficacy-Efficacy Scale" will be applied as a pre-test after the briefing. High-fidelity simulator application training will be applied to the intervention group students, accompanied by a scenario, and case-based learning method will be applied to the control group students. After the training, "State Anxiety Inventory", "Self-Efficacy-Efficacy Scale" and "Satisfaction with Educational Methods Questionnaire" will be administered to all students. Three months after the training, the "State Anxiety Inventory" and "Self-Efficacy-Efficacy Scale" will be administered to the students again.

Study Overview

• Status: Not yet recruiting
• Conditions: Fetal Monitoring
• Intervention / Treatment: Other: Simulation-based electronic fetal monitoring training

Detailed Description

It was planned to determine the effect of scenario-based high-reality Electronic Fetal Monitoring (EFM) simulation method on midwifery students' self-efficacy, competence and situational anxiety levels.

The population of the research will be Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department 3rd year students (N:80). In this study, which was planned as a quasi-experimental pre- and post-test design and with a control group, all students who are actively studying in the 3rd year of the midwifery department, whose sample selection was not made, will form the scope of the research, and individuals who volunteered to participate in the study will form the sample of the research.

The students who volunteered to participate in the study will be assigned to the intervention and control groups with a computer-assisted simple random sampling method. Computer-assisted randomization will be used in the study, and random assignment will be made to the intervention and control groups by entering the number of cases through the program whose URL is https://www.randomizer.org. After 4 hours of theoretical training on EFM application and interpretation are given to all students, intervention group students will be given a scenario-accompanied high-validity simulation laboratory application, and control group students will be given only case-based learning technique.

All groups will be informed before the applications. In this context, a question-and-answer session will be held by giving information about the applications to be made regarding the research. Students will be given information about the introduction of the simulator and the model, the flow chart of the training plan, the content of the training plan, the environment, the locations of the materials. 40 students selected for the intervention group will be given high-fidelity simulator and information on case-based learning will be given to 40 students selected for the training and control group. Before the application, all groups will be given theoretical information about electronic fetal monitoring for 4 hours with a power point presentation. "State Anxiety Inventory" and "Self-Efficacy Scale" will be applied as a pre-test after the briefing. High-fidelity simulator application training will be applied to the intervention group students, accompanied by a scenario, and case-based learning method will be applied to the control group students. After the training, "State Anxiety Inventory", "Self-Efficacy Scale" and "Satisfaction with Educational Methods Questionnaire" will be administered to all students. Three months after the training, the "State Anxiety Inventory" and "Self-Efficacy Scale" will be administered to the students again.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasemin Aydın Kartal Assoc. Prof. Dr.; Phone Number: +90 543 287 00 29; Email: yasemin.aydin@sbu.edu.tr
• Study Contact Backup: Name: Aleyna Bulut Research Assistant; Phone Number: +90 536 562 61 84; Email: aleyna.bulut@sbu.edu.tr

Study Locations

• Turkey
  • None Selected
    • Istanbul, None Selected, Turkey
      • University of Health Sciences
      • Contact: Yasemin Aydın Kartal Assoc. Prof. Dr.; Phone Number: +90 543 287 00 29; Email: yasemin.aydin@sbu.edu.tr
      • Contact: Aleyna Bulut Research Assistant; Phone Number: +90 536 562 61 84; Email: aleyna.bulut@sbu.edu.tr
      • Principal Investigator: Yasemin Aydın Kartal Assoc. Prof. Dr.
      • Sub-Investigator: Aleyna Bulut Research Assistant
      • Sub-Investigator: Sema Aker Research Assistant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Volunteering to participate in the research.
• Being a third year student at SBU, Hamidiye Faculty of Health Sciences, Midwifery Department.

Exclusion Criteria:

• Not volunteering to participate in the research.
• Not to be a third year student at the Faculty of Health Sciences, Hamidiye, Department of Midwifery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervention group (High validity simulation application group) (n:40); Practices will be carried out with the students in the intervention group with the "NOELLA Birth Simulator", which is a high-reality simulator located in the Simulation laboratory of the Department of Midwifery of the Faculty of Health Sciences of Hamidiye. A simulator will be practiced with a separate scenario including early, late, variable deceleration, reactive, sinusoidal and non-reactive trace interpretation and intervention.	Other: Simulation-based electronic fetal monitoring training; Practices will be carried out with the students in the intervention group with the "NOELLA Birth Simulator", which is a high-reality simulator located in the Simulation laboratory of the Department of Midwifery of the Faculty of Health Sciences of Hamidiye. A simulator will be practiced with a separate scenario including early, late, variable deceleration, reactive, sinusoidal and non-reactive trace interpretation and intervention.
No Intervention: Control group (Case-based teaching technique group) (n:40); To the control group students; Cases on early, late, variable deceleration, reactive, sinusoidal and non-reactive tracing will be prepared by dividing into groups of 5 people. Semi-structured cases will be evaluated and clinical intervention will be discussed with group work. Practice will be done in the basic skills laboratory of the midwifery department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Introductory Information Form	In this form, which was created by the researchers based on the literature, participants' age, high school they graduated from, willingly choosing the profession, feeling of belonging to the profession, etc. questions are included.	One hour before the education
State-Trait Anxiety Inventory	The scale consists of two subscales, continuous and state, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how the individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how the individual feels independently of the situation and conditions. The scores obtained from the scale theoretically vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.	One hour before the education
Self-Efficacy Scale	The scale, which does not belong to any subjective domain, measures the perception of general self-efficacy and efficacy. The Self-Efficacy Scale is structured as a 5-point Likert-type scale consisting of 23 items, and a minimum of 23 and a maximum of 115 points can be obtained from the scale. For each item on the scale, one of the options 1-Does not describe me at all, 2-Describes me a little, 3-I am undecided, 4-Describes me well, 5-Describes me very well, is based on the score given for each item. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 on the scale are scored in the opposite direction. An increase in the total score that can be obtained from the scale indicates that the general self-efficacy perception is high.	One hour before the education

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory	The scale consists of two subscales, continuous and state, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how the individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how the individual feels independently of the situation and conditions. The scores obtained from the scale theoretically vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.	After education
Self-Efficacy Scale	The scale, which does not belong to any subjective domain, measures the perception of general self-efficacy and efficacy. The Self-Efficacy Scale is structured as a 5-point Likert-type scale consisting of 23 items, and a minimum of 23 and a maximum of 115 points can be obtained from the scale. For each item on the scale, one of the options 1-Does not describe me at all, 2-Describes me a little, 3-I am undecided, 4-Describes me well, 5-Describes me very well, is based on the score given for each item. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 on the scale are scored in the opposite direction. An increase in the total score that can be obtained from the scale indicates that the general self-efficacy perception is high.	After education
Satisfaction Survey with Training Methods	The questionnaire consists of 16 propositions. One of these propositions is the proposition "I am satisfied with this education method in general", which questions the state of being satisfied with the education. Other propositions were formed from propositions aiming to determine the views of the education method in general about the contribution of the education method to the learning and professional life of the student. Each proposition is scored on a 5-point Likert scale (1-strongly disagree, 5-strongly agree). It is determined that as the scale score average increases, students' satisfaction with the education method increases, and as the scale score average decreases, their satisfaction with the education method decreases.	After education

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory	The scale consists of two subscales, continuous and state, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how the individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how the individual feels independently of the situation and conditions. The scores obtained from the scale theoretically vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.	Three months after the education
Self-Efficacy Scale	The scale, which does not belong to any subjective domain, measures the perception of general self-efficacy and efficacy. The Self-Efficacy Scale is structured as a 5-point Likert-type scale consisting of 23 items, and a minimum of 23 and a maximum of 115 points can be obtained from the scale. For each item on the scale, one of the options 1-Does not describe me at all, 2-Describes me a little, 3-I am undecided, 4-Describes me well, 5-Describes me very well, is based on the score given for each item. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 on the scale are scored in the opposite direction. An increase in the total score that can be obtained from the scale indicates that the general self-efficacy perception is high.	Three months after the education

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Yasemin Aydın Kartal Assoc. Prof. Dr., Saglik Bilimleri Universitesi; Study Chair: Aleyna Bulut Research Assistant, Saglik Bilimleri Universitesi; Study Chair: Sema Aker Research Assistant, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: simulation; midwifery students; EFM
• Other Study ID Numbers: SBÜ-AYDINKARTAL-004

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