NCT05354518

Brief Summary

Gestational Diabetes Mellitus is one of the common risk factors of pregnancy and occurs for the first time during pregnancy. It adversely affects maternal and fetal health and causes an increase in morbidity and mortality rates. In this context, it is very important to identify possible risks for GDM, plan, implement and evaluate initiatives, provide emergency crisis management in a short time without damage, and increase the self-confidence of midwives. In recent years, interest in simulation methods and skill acquisition training in midwifery education has increased. Research; In the management of GDM, to increase the satisfaction and self-confidence level of midwifery students in learning, to evaluate the simulation design and educational effectiveness, it was planned to use the scenario-based near-realistic simulation method in the form of randomized control-intervention quantitatively, and in qualitative design to evaluate the students' views on the method and educational effectiveness. The research will make it easier for midwifery students to intervene with the patient in a shorter time, with confidence and with sufficient clinical skills, and patient safety will be increased. In addition, it will allow the reduction of erroneous clinical practices and malpractices. This study aims to evaluate the satisfaction and self-confidence status of midwifery students and the educational effectiveness of the scenario-based simulation method with high closeness to reality in GDM management and to examine the opinions about this method to fill the gap in the literature.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

Same day

First QC Date

April 17, 2022

Last Update Submit

April 23, 2022

Conditions

Outcome Measures

Primary Outcomes (8)

  • information evaluation form

    The information evaluation form is in a multiple-choice format consisting of 25 questions by scanning the literature by the researchers. Each question is worth 4 points.

    immediately before simulation

  • information evaluation form

    The information evaluation form is in a multiple-choice format consisting of 25 questions by scanning the literature by the researchers. Each question is worth 4 points.

    7 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

  • 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 third 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.

    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.

    immediately after the second 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.

    immediately after the third simulation application

Secondary Outcomes (1)

  • Semi-Structured Focus Group Training Activity Evaluation Form

    7 weeks after starting the study

Study Arms (2)

gestational diabetes management simulation

EXPERIMENTAL
Behavioral: gestational diabetes management of midwifery students

no intervention will be made

NO INTERVENTION

Interventions

Gestational diabetes management of midwifery students with a simulator

gestational diabetes management simulation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Agreeing to participate in the research,
  • Being a midwifery 3rd year student and taking the "risky pregnancy" course,
  • Those who have no previous clinical experience in GDM (Health College, Health Vocational High School Graduate, etc.)

You may not qualify if:

  • To fill in the data collection forms of the study incompletely,
  • Not participating in all applications of simulation training with high proximity to reality,
  • Desire to leave the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 29, 2022

Study Start

April 19, 2022

Primary Completion

April 19, 2022

Study Completion

May 31, 2024

Last Updated

April 29, 2022

Record last verified: 2022-04