Determining the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-EfficacyNCT06897397
Determination of the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-Efficacy
A study testing Case Study in people with Determining the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-Efficacy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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… 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
- Determining the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-Efficacy
- What is being tested?
- Case Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2024to 15 Mar 2025
- 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
- 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.
Who cannot join
- Being a passive student in the 2nd year of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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".
- Being tested
- Case Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case StudyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (n:40) | Experimental | 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. Receives: Other: Case Study |
| Control group (n:40 | No intervention | Control group students will receive 4 hours of theoretical training. The training will be held in the midwifery department lecture hall. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
This form, created by researchers based on literature, includes questions about the participants' age, high school graduation, case-based education status, etc.
Measured: 10 minutes
Electronic Fetal Monitoring Self-Efficacy Scale
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.
Measured: 10 minutes
Secondary outcomes (2)
Introductory Information Form
This form, created by researchers based on literature, includes questions about the participants' age, high school graduation, case-based education status, etc.
Measured: 10 minutes
Electronic Fetal Monitoring Self-Efficacy Scale
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start5 May 2024
- Primary completion5 Oct 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determining the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-EfficacyStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897397
- Sponsor's protocol ID
- SBU-AYDINKARTAL-010
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-Efficacy
- ClinicalTrials.gov ID
- NCT06897397
- Acronym / sponsor ID
- SBU-AYDINKARTAL-010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 26 Mar 2025 (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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (n:40) | Experimental | Other: Case StudyStudents 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. |
| Control group (n:40 | No intervention | –Control group students will receive 4 hours of theoretical training. The training will be held in the midwifery department lecture hall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Being a passive student in the 2nd year of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences.
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 |
|---|---|---|
| Case StudyStudents 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. | Other | Intervention group (n:40) |
Primary outcome
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.
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.
2 secondary outcomes
Introductory Information Form
Time frame: 10 minutes
Electronic Fetal Monitoring Self-Efficacy Scale
Time frame: 10 minutes
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 26 Mar 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Study in people with Determining the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-Efficacy, 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 1 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 26 Mar 2025. 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?
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?
Introductory Information Form (time frame: 10 minutes). The study lists 2 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 26 Mar 2025.