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Teaching Method With Simulation in Gestational Diabetes Mellitus Management

Primary Purpose

Diabetes, Gestational

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gestational diabetes management of midwifery students
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes, Gestational

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    gestational diabetes management simulation

    no intervention will be made

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Semi-Structured Focus Group Training Activity Evaluation Form
    It is a form consisting of 5 semi-structured questions created by the researchers after a comprehensive literature search in order to evaluate the simulation training effectiveness. With these questions, it was aimed to determine the strengths and weaknesses of training with the simulation method regarding GDM management, the opportunities/opportunities it provides and the threats and dangers created by this method.

    Full Information

    First Posted
    April 17, 2022
    Last Updated
    April 23, 2022
    Sponsor
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05354518
    Brief Title
    Teaching Method With Simulation in Gestational Diabetes Mellitus Management
    Official Title
    Evaluation of the Effectiveness of Teaching Method With Simulation in Gestational Diabetes Mellitus Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 19, 2022 (Anticipated)
    Primary Completion Date
    April 19, 2022 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saglik Bilimleri Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Gestational

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gestational diabetes management simulation
    Arm Type
    Experimental
    Arm Title
    no intervention will be made
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    gestational diabetes management of midwifery students
    Intervention Description
    Gestational diabetes management of midwifery students with a simulator
    Primary Outcome Measure Information:
    Title
    information evaluation form
    Description
    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.
    Time Frame
    immediately before simulation
    Title
    information evaluation form
    Description
    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.
    Time Frame
    7 weeks after the first simulation application
    Title
    Student Satisfaction and Self-Confidence Scale in Learning
    Description
    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.
    Time Frame
    immediately after the first simulation application
    Title
    Student Satisfaction and Self-Confidence Scale in Learning
    Description
    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.
    Time Frame
    immediately after the second simulation application
    Title
    Student Satisfaction and Self-Confidence Scale in Learning
    Description
    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.
    Time Frame
    immediately after the third simulation application
    Title
    Simulation Design Scale
    Description
    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.
    Time Frame
    immediately after the first simulation application
    Title
    Simulation Design Scale
    Description
    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.
    Time Frame
    immediately after the second simulation application
    Title
    Simulation Design Scale
    Description
    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.
    Time Frame
    immediately after the third simulation application
    Secondary Outcome Measure Information:
    Title
    Semi-Structured Focus Group Training Activity Evaluation Form
    Description
    It is a form consisting of 5 semi-structured questions created by the researchers after a comprehensive literature search in order to evaluate the simulation training effectiveness. With these questions, it was aimed to determine the strengths and weaknesses of training with the simulation method regarding GDM management, the opportunities/opportunities it provides and the threats and dangers created by this method.
    Time Frame
    7 weeks after starting the study

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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.) Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esra YILMAZ
    Phone
    +905072025738
    Email
    esrayilmaz939@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Besey ÖREN
    Phone
    +905327756206
    Email
    besey.oren@sbu.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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