Diabetes, GestationalNCT05354518
Teaching Method With Simulation in Gestational Diabetes Mellitus Management
A study testing gestational diabetes management of midwifery students in people with Diabetes, Gestational, run by Saglik Bilimleri Universitesi.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- gestational diabetes management of midwifery students
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effectiveness of Teaching Method With Simulation in Gestational Diabetes Mellitus Management
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.
- Conditions
- Diabetes, Gestational
- Being tested
- gestational diabetes management of midwifery students
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gestational diabetes management of midwifery studentsBehavioural
Gestational diabetes management of midwifery students with a simulator
| Study group | Role | What they receive |
|---|---|---|
| gestational diabetes management simulation | Experimental | Not described Receives: Behavioral: gestational diabetes management of midwifery students |
| no intervention will be made | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after the third simulation application
Secondary outcomes (1)
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.
Measured: 7 weeks after starting the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start19 Apr 2022 (estimated)
- Primary completion19 Apr 2022 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Yılmaz, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354518
- Sponsor's protocol ID
- sbu_yılmaz38
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Teaching Method With Simulation in Gestational Diabetes Mellitus Management
- ClinicalTrials.gov ID
- NCT05354518
- Acronym / sponsor ID
- sbu_yılmaz38
- Conditions
- Diabetes, Gestational
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 19 Apr 2022 (estimated)
- Primary completion
- 19 Apr 2022 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gestational diabetes management simulation | Experimental | Behavioral: gestational diabetes management of midwifery students |
| no intervention will be made | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gestational diabetes management of midwifery studentsGestational diabetes management of midwifery students with a simulator | Behavioural | gestational diabetes management simulation |
Primary outcome
information evaluation form
Time frame: immediately before simulation
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
Time frame: 7 weeks after the first simulation application
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
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.
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.
Student Satisfaction and Self-Confidence Scale in Learning
Time frame: immediately after the third 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.
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.
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.
Simulation Design Scale
Time frame: immediately after the third 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.
1 secondary outcome
Semi-Structured Focus Group Training Activity Evaluation Form
Time frame: 7 weeks after starting the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing gestational diabetes management of midwifery students in people with Diabetes, Gestational, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra YILMAZ (+905072025738, esrayilmaz939@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
information evaluation form (time frame: immediately before simulation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.