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

Fetal Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933928
• Other study ID #: SBÜ-AYDINKARTAL-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: July 2023
• Source: Saglik Bilimleri Universitesi
• Contact: Yasemin Aydin Kartal Assoc. Prof. Dr.
• Phone: +90 543 287 00 29
• Email: yasemin.aydin[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Monitoring

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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Istanbul	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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