NCT05933928

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

June 24, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

EFMmidwifery studentssimulation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    One hour before the education

Secondary Outcomes (3)

  • State-Trait Anxiety Inventory

    After education

  • Self-Efficacy Scale

    After education

  • Satisfaction Survey with Training Methods

    After education

Other Outcomes (2)

  • State-Trait Anxiety Inventory

    Three months after the education

  • Self-Efficacy Scale

    Three months after the education

Study Arms (2)

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.

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.

Interventions

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.

İntervention group (High validity simulation application group) (n:40)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the research.
  • Being a third year student at SBU, Hamidiye Faculty of Health Sciences, Midwifery Department.

You may not qualify if:

  • Not volunteering to participate in the research.
  • Not to be a third year student at the Faculty of Health Sciences, Hamidiye, Department of Midwifery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, None Selected, Turkey (Türkiye)

Location

Study Officials

  • Yasemin Aydın Kartal Assoc. Prof. Dr.

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR
  • Aleyna Bulut Research Assistant

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Sema Aker Research Assistant

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Central Study Contacts

Yasemin Aydın Kartal Assoc. Prof. Dr.

CONTACT

Aleyna Bulut Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled single-blind quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 6, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations