NCT05904314

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

April 27, 2026

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

April 17, 2023

Last Update Submit

April 24, 2026

Conditions

Keywords

Electro fetal monitorhigh-fidelity simulationsatisfactionself-confidence

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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.

    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.

    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.

    immediately after the second simulation application

Secondary Outcomes (3)

  • Simulation Design Scale

    immediately after the first simulation application

  • Simulation Design Scale

    immediately after the second simulation application

  • Self-efficacy scale in monitoring and management of electronic fetal monitoring

    immediately after the first simulation application

Study Arms (2)

Experimental Group

EXPERIMENTAL

Investigation of the effectiveness of scenario-based standardized patient simulation training and electronic fetal monitor management of midwifery students

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

Interventions

Simulation training in electronic fetal monitor management

Experimental Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete filling of data collection forms,
  • Not participating in all applications of simulation teaching,
  • Desire to leave the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Iffet Güler Kaya

Fatih, Istanbul, 34200, Turkey (Türkiye)

Location

Neriman

Istanbul, 34220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 68 participants, control group theory training experimental group Electronic fetal monitor management simulation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

June 15, 2023

Study Start

December 15, 2022

Primary Completion

July 5, 2023

Study Completion

August 10, 2024

Last Updated

April 27, 2026

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Can be used for a long time
Access Criteria
Undecided

Locations