Fetal MonitoringNCT05933928
The Effect of Simulation-based Electronic Fetal Monitoring Training on Midwifery Students
A study testing Simulation-based electronic fetal monitoring training in people with Fetal Monitoring, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Monitoring
- What is being tested?
- Simulation-based electronic fetal monitoring training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research.
- Being a third year student at SBU, Hamidiye Faculty of Health Sciences, Midwifery Department.
Who cannot join
- Not volunteering to participate in the research.
- Not to be a third year student at the Faculty of Health Sciences, Hamidiye, Department of Midwifery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, None Selected
Yasemin Aydın Kartal Assoc. Prof. Dr., +90 543 287 00 29, yasemin.aydin@sbu.edu.tr
Aleyna Bulut Research Assistant, +90 536 562 61 84, aleyna.bulut@sbu.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Monitoring
- Being tested
- Simulation-based electronic fetal monitoring training
- Keywords
- EFM, midwifery students, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based electronic fetal monitoring trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group (High validity simulation application group) (n:40) | Experimental | 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. Receives: Other: Simulation-based electronic fetal monitoring training |
| Control group (Case-based teaching technique group) (n:40) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One hour before the education
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: After education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MonitoringStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled single-blind quasi-experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
- Investigators
- Yasemin Aydın Kartal Assoc. Prof. Dr., Principal investigator, Saglik Bilimleri UniversitesiAleyna Bulut Research Assistant, Study chair, Saglik Bilimleri UniversitesiSema Aker Research Assistant, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933928
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-004
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Electronic Fetal Monitoring Training on Self-Efficacy-Efficacy and Anxiety Levels of Midwifery Students
- ClinicalTrials.gov ID
- NCT05933928
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-004
- Conditions
- Fetal Monitoring
- Keywords
- EFM, midwifery students, simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled single-blind quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| İntervention group (High validity simulation application group) (n:40) | Experimental | Other: Simulation-based electronic fetal monitoring trainingPractices 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. |
| Control group (Case-based teaching technique group) (n:40) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteering to participate in the research.
- Being a third year student at SBU, Hamidiye Faculty of Health Sciences, Midwifery Department.
Key exclusion criteria (2 listed)
- Not volunteering to participate in the research.
- Not to be a third year student at the Faculty of Health Sciences, Hamidiye, Department of Midwifery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based electronic fetal monitoring trainingPractices 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 | İntervention group (High validity simulation application group) (n:40) |
Primary outcome
Introductory Information Form
Time frame: One hour before the education
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.
State-Trait Anxiety Inventory
Time frame: One hour before the education
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.
Self-Efficacy Scale
Time frame: One hour before the education
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.
3 secondary outcomes
State-Trait Anxiety Inventory
Time frame: After education
Self-Efficacy Scale
Time frame: After education
Satisfaction Survey with Training Methods
Time frame: After education
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Aydın Kartal Assoc. Prof. Dr. principal investigator
Saglik Bilimleri Universitesi
Aleyna Bulut Research Assistant study chair
Saglik Bilimleri Universitesi
Sema Aker Research Assistant study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based electronic fetal monitoring training in people with Fetal Monitoring, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Aydın Kartal Assoc. Prof. Dr. (+90 543 287 00 29, yasemin.aydin@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: One hour before the education). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.