CardiotocographyEFMNCT05904314
Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management
A study testing Simulation training in electronic fetal monitor management in people with Cardiotocography and Electronic Fetal Monitoring, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
Electro fetal monitor monitoring in the antepartum and intrapartum periods is one of the most important responsibilities of midwives, who have important roles and responsibilities in maintaining and managing the health of women and newborns before, during and after delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cardiotocography, Electronic Fetal Monitoring, High Fidelity Simulation Training
- What is being tested?
- Simulation training in electronic fetal monitor management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 10 Aug 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Agreeing to participate in the research,
- Being a midwifery second year student and taking the "Risky pregnancy" course,
- Attending training with simulation for the first time
Who cannot join
- Incomplete filling of data collection forms,
- Not participating in all applications of simulation teaching,
- Desire to leave the research.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Iffet Güler Kaya
Fatih, Istanbul, 34200
Neriman
Istanbul, 34220
About this study
Official title: The Effect Of Simulation Teaching Method On Students' Knowledge, Satisfaction, And Self-Efficacy İn Electronic Fetal Monitoring Follow Up And Management
Electro fetal monitor monitoring in the antepartum and intrapartum periods is one of the most important responsibilities of midwives, who have important roles and responsibilities in maintaining and managing the health of women and newborns before, during and after delivery. Although midwives receive training on EFM monitoring with classical methods before graduation, they may experience problems in EFM monitoring in the clinical field after graduation. For this reason, midwife students should have the knowledge, skills and self-efficacy about a good level of EFM monitoring during their undergraduate education. In recent years, simulation-based education in the field of health has increased rapidly. This method creates an opportunity for health professionals, students, patient assessment, interaction and holistic care without compromising patient safety, and develops participants' critical thinking, clinical decision making and problem solving skills.
In this context, it is very important to evaluate the EFM trace in the antepartum and intrapartum periods, to determine the possible risks, to plan, implement and evaluate the interventions, to provide the emergency crisis management in a short time without affecting the fetal health, and to increase the self-confidence of the midwives.
Read more
The research was planned quantitatively in the form of randomized control-intervention of the scenario-based realistic simulation method, to increase the satisfaction and self-confidence levels of midwifery students in learning, to evaluate the simulation design and educational effectiveness, in EFM management. The research will facilitate midwifery students to intervene with the patient in a shorter time, with confidence and with sufficient clinical skills, and patient safety will be increased. It will also allow for the reduction of erroneous clinical practices and malpractices.
This research aims to evaluate the effect of high-fidelity simulation teaching method on knowledge, satisfaction and self-efficacy of midwifery students in EFM follow-up.
- Being tested
- Simulation training in electronic fetal monitor management
- Keywords
- Electro fetal monitor, high-fidelity simulation, satisfaction, self-confidence
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation training in electronic fetal monitor managementBehavioural
Simulation training in electronic fetal monitor management
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Investigation of the effectiveness of scenario-based standardized patient simulation training and electronic fetal monitor management of midwifery students Receives: Behavioral: Simulation training in electronic fetal monitor management |
| Control Group | No intervention | Behavioral: Examining the effectiveness of electronic fetal monitor management of midwifery students with theory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
information evaluation form
The information evaluation form is in a multiple-choice format consisting of 50 questions by scanning the literature by the researchers. Each question is worth 2 points
Measured: immediately before simulation
information evaluation form
The information evaluation form is in a multiple-choice format consisting of 50 questions by scanning the literature by the researchers. Each question is worth 2 points
Measured: 5 weeks after the first simulation application
Student Satisfaction and Self-Confidence Scale in Learning
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.
Measured: immediately after the first simulation application
Student Satisfaction and Self-Confidence Scale in Learning
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.
Measured: immediately after the second simulation application
Self-efficacy scale in monitoring and management of electronic fetal monitoring
It has been determined that the 32-item scale .Electro Fetal Monitor Monitoring Scale can be used as a valid and reliable scale in health professionals. Minimum 0, maximum 32. As the score increases, it is determined that the self-efficacy is higher.
Measured: immediately after the second simulation application
Secondary outcomes (3)
Simulation Design Scale
The simulation method applied and designed to the intervention group is used in the evaluation of the participants. The simulation design scale consists of 20 items in total. Evaluation of the scale is done in two stages. In the first stage, in order to evaluate whether the items used in the simulation method were given in the best way for the participant, they were expressed as strongly disagree, disagree, undecided, agree, strongly agree. In the second stage, there are statements that will determine the level of importance of the scale items for the participant, not important, partially important, undecided, important, very important. In the evaluation phase, the scale score is calculated by dividing the total and the total of the sub-dimensions by the number of items.
Measured: immediately after the first simulation application
Simulation Design Scale
The simulation method applied and designed to the intervention group is used in the evaluation of the participants. The simulation design scale consists of 20 items in total. Evaluation of the scale is done in two stages. In the first stage, in order to evaluate whether the items used in the simulation method were given in the best way for the participant, they were expressed as strongly disagree, disagree, undecided, agree, strongly agree. In the second stage, there are statements that will determine the level of importance of the scale items for the participant, not important, partially important, undecided, important, very important. In the evaluation phase, the scale score is calculated by dividing the total and the total of the sub-dimensions by the number of items.
Measured: immediately after the second simulation application
Self-efficacy scale in monitoring and management of electronic fetal monitoring
It has been determined that the 32-item scale. Electro Fetal Monitor Monitoring Scale can be used as a valid and reliable scale in health professionals. Minimum 0, maximum 32. As the score increases, it is determined that the self-efficacy is higher.
Measured: immediately after the first simulation application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Dec 2022
- Primary completion5 Jul 2023
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotocographyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 68 participants, control group theory training experimental group Electronic fetal monitor management simulation
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904314
- Sponsor's protocol ID
- IGULER
- Acronym
- EFM
- Status last verified
- Jun 2024
- First submitted
- 17 Apr 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This research aims to evaluate the effect of high-fidelity simulation teaching method on knowledge, satisfaction and self-efficacy of midwifery students in EFM follow-up.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Simulation Teaching Method On Students' Knowledge, Satisfaction, And Self-Efficacy İn Electronic Fetal Monitoring Follow Up And Management
- ClinicalTrials.gov ID
- NCT05904314
- Acronym / sponsor ID
- EFM / IGULER
- Keywords
- Electro fetal monitor, high-fidelity simulation, satisfaction, self-confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 15 Jun 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.
Electro fetal monitor monitoring in the antepartum and intrapartum periods is one of the most important responsibilities of midwives, who have important roles and responsibilities in maintaining and managing the health of women and newborns before, during and after delivery. Although midwives receive training on EFM monitoring with classical methods before graduation, they may experience problems in EFM monitoring in the clinical field after graduation. For this reason, midwife students should have the knowledge, skills and self-efficacy about a good level of EFM monitoring during their undergraduate education. In recent years, simulation-based education in the field of health has increased rapidly. This method creates an opportunity for health professionals, students, patient assessment, interaction and holistic care without compromising patient safety, and develops participants' critical thinking, clinical decision making and problem solving skills.
In this context, it is very important to evaluate the EFM trace in the antepartum and intrapartum periods, to determine the possible risks, to plan, implement and evaluate the interventions, to provide the emergency crisis management in a short time without affecting the fetal health, and to increase the self-confidence of the midwives.
The research was planned quantitatively in the form of randomized control-intervention of the scenario-based realistic simulation method, to increase the satisfaction and self-confidence levels of midwifery students in learning, to evaluate the simulation design and educational effectiveness, in EFM management. The research will facilitate midwifery students to intervene with the patient in a shorter time, with confidence and with sufficient clinical skills, and patient safety will be increased. It will also allow for the reduction of erroneous clinical practices and malpractices.
This research aims to evaluate the effect of high-fidelity simulation teaching method on knowledge, satisfaction and self-efficacy of midwifery students in EFM follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 68 participants, control group theory training experimental group Electronic fetal monitor management simulation
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Simulation training in electronic fetal monitor managementInvestigation of the effectiveness of scenario-based standardized patient simulation training and electronic fetal monitor management of midwifery students |
| Control Group | No intervention | –Behavioral: Examining the effectiveness of electronic fetal monitor management of midwifery students with theory training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Agreeing to participate in the research,
- Being a midwifery second year student and taking the "Risky pregnancy" course,
- Attending training with simulation for the first time
Key exclusion criteria (3 listed)
- Incomplete filling of data collection forms,
- Not participating in all applications of simulation teaching,
- Desire to leave the research.
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 training in electronic fetal monitor managementSimulation training in electronic fetal monitor management | Behavioural | Experimental Group |
Primary outcome
information evaluation form
Time frame: immediately before simulation
The information evaluation form is in a multiple-choice format consisting of 50 questions by scanning the literature by the researchers. Each question is worth 2 points
information evaluation form
Time frame: 5 weeks after the first simulation application
The information evaluation form is in a multiple-choice format consisting of 50 questions by scanning the literature by the researchers. Each question is worth 2 points
Student Satisfaction and Self-Confidence Scale in Learning
Time frame: immediately after the first simulation application
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.
Student Satisfaction and Self-Confidence Scale in Learning
Time frame: immediately after the second simulation application
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.
Self-efficacy scale in monitoring and management of electronic fetal monitoring
Time frame: immediately after the second simulation application
It has been determined that the 32-item scale .Electro Fetal Monitor Monitoring Scale can be used as a valid and reliable scale in health professionals. Minimum 0, maximum 32. As the score increases, it is determined that the self-efficacy is higher.
3 secondary outcomes
Simulation Design Scale
Time frame: immediately after the first simulation application
Simulation Design Scale
Time frame: immediately after the second simulation application
Self-efficacy scale in monitoring and management of electronic fetal monitoring
Time frame: immediately after the first simulation application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. This research aims to evaluate the effect of high-fidelity simulation teaching method on knowledge, satisfaction and self-efficacy of midwifery students in EFM follow-up.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation training in electronic fetal monitor management in people with Cardiotocography and Electronic Fetal Monitoring, run by Saglik Bilimleri Universitesi at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
information evaluation form (time frame: immediately before simulation). The study lists 5 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 27 Apr 2026.