- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05904314
Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management (EFM)
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34220
- Neriman
-
-
Istanbul
-
Fatih, Istanbul, Turkey (Türkiye), 34200
- Iffet Güler Kaya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Incomplete filling of data collection forms,
- Not participating in all applications of simulation teaching,
- Desire to leave the research.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Investigation of the effectiveness of scenario-based standardized patient simulation training and electronic fetal monitor management of midwifery students
|
Simulation training in electronic fetal monitor management
|
|
No Intervention: Control Group
Behavioral: Examining the effectiveness of electronic fetal monitor management of midwifery students with theory training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
immediately after the first simulation application
|
|
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.
|
immediately after the second simulation application
|
|
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
|
immediately before simulation
|
|
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
|
5 weeks after the first simulation application
|
|
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.
|
immediately after the second simulation application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulation Design Scale
Time Frame: immediately after the first simulation application
|
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.
|
immediately after the first simulation application
|
|
Simulation Design Scale
Time Frame: immediately after the second simulation application
|
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.
|
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
|
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.
|
immediately after the first simulation application
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGULER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiotocography
-
University of Illinois at ChicagoTerminated
-
Rambam Health Care CampusTechnion, Israel Institute of TechnologyNot yet recruiting
-
Birmingham Women's NHS Foundation TrustRecruitingPregnancy | Telemedicine | Cardiotocography | High Risk | TelemonitoringUnited Kingdom
-
Birmingham Women's NHS Foundation TrustGE Healthcare; Nestmedic S.A.CompletedPregnancy, High Risk | Telemedicine | Ultrasound | Cardiotocography | TelemonitoringUnited Kingdom
-
Maxima Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingCaesarean Section | Electrocardiography | Cardiotocography | Fetal Monitoring | Non-invasiveNetherlands
-
Rawalpindi Medical CollegeRawalpindi Medical College, PakistanRecruitingSteroids | CardiotocographyPakistan
-
University Hospital Inselspital, BerneCSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et...UnknownTo Introduce Artificial Intelligence (AI) and Machine Learning in Cardiotocography (CTG) Interpretation to Improve Clinical UseSwitzerland
-
University of Campania "Luigi Vanvitelli"UnknownSepsis | Premature Birth | Premature Rupture of Membrane | Cardiotocography | Rupture of Membranes; PrematureItaly
Clinical Trials on Simulation training in electronic fetal monitor management
-
Saglik Bilimleri UniversitesiNot yet recruitingFetal MonitoringTurkey
-
OBMedical CompanyUniversity of FloridaCompleted
-
Selcuk UniversityEnrolling by invitationMaternal Health | EducationTurkey (Türkiye)
-
National Taiwan University HospitalRecruitingAdult Non-trauma Cardiac Arrest Resuscitation | Effectiveness of In-situ Simulation (ISS) Training | Effectiveness of Off-site Simulation (OSS) Training | Improvement of Teamwork in Emergency Care SettingsTaiwan
-
Institut Mutualiste MontsourisCompletedLearning | Role Playing | PsychologyFrance
-
Universidad de AntioquiaCompleted
-
Odense University HospitalCompletedSimulation | Endoscopy | Education | GastroscopyDenmark
-
Saglik Bilimleri UniversitesiCompletedPostpartum HemorrhageTurkey
-
St. Justine's HospitalCHU de Quebec-Universite Laval; Université de Sherbrooke; Jewish General Hospital and other collaboratorsCompletedIntubation | Education | Simulation TrainingCanada
-
Tri-Service General HospitalCompletedNursing Education | Simulation Training | Simulation-Based LearningTaiwan