SimulationNCT06218095
Pregnancy and Postpartum Period Venous Thromboembolism and Simulation
A study testing Simulation application in people with Simulation and Venous Thromboembolism, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This research will be carried out to determine the effectiveness of teaching thromboembolism risk assessment during pregnancy and postpartum period to midwifery students using a high-tech simulation method. Thromboembolism during pregnancy and postpartum period is one of the preventable causes of maternal deaths. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simulation, Venous Thromboembolism
- What is being tested?
- Simulation application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 10 Aug 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having a statement of consent
- Being a third year midwifery student
- Having taken the risky pregnancy and birth course
Who cannot join
- Wishing to withdraw from the research at any time.
- Not participating in all simulation applications
- Incompletely filling out data collection forms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Midwifery Simulation Laboratory
Istanbul, Üsküdar, 34668
About this study
Official title: Investigation of Simulation Teaching Efficiency in Evaluation of Thromboembolism Risk in Pregnancy and Postpartum Period
This research will be carried out to determine the effectiveness of teaching thromboembolism risk assessment during pregnancy and postpartum period to midwifery students using a high-tech simulation method.
Thromboembolism during pregnancy and postpartum period is one of the preventable causes of maternal deaths. For this reason, it is important to determine the thromboembolism risk of pregnant women and postpartum women by midwives before complications develop and to plan preventive interventions. The aim of the research is to provide midwifery students with the ability to evaluate the risk of thromboembolism before clinical experience through high-tech simulation application.
Read more
Goals;
- To increase midwifery students' skills in assessing thromboembolism risk during pregnancy and postpartum period before clinical practice.
- To increase the self-confidence and satisfaction of midwifery students with simulation application in pregnancy and postpartum thromboembolism risk assessment skills.
- To develop midwifery students' quick, critical thinking and decision-making skills in assessing the risk of thromboembolism before clinical practice.
- To help midwifery students visualize the risk of pregnancy and postpartum thromboembolism, which has an important place in terms of maternal deaths, by creating a clinical environment with a case scenario.
- To determine the effectiveness of midwifery teaching through case scenario simulation application with the risk of pregnancy and postpartum thromboembolism, and to increase students' learning and clinical practice skills.
Read the detailed description
Design of the Research: Researchers will receive scenario creation and simulation design training for the advanced technology simulation method. After the simulation training, pregnancy and postpartum thromboembolism scenarios will be prepared for the intervention group. A thromboembolism information form will be prepared for the intervention and control groups. Expert opinions will be obtained from at least 6 people who are experts in the field of risky pregnancy and postpartum on the forms and scenarios prepared by the researcher. In line with expert opinions, the scenarios and thromboembolism information form will be finalized. The scenarios and forms prepared for the intervention group will be piloted with 6 3rd year midwifery students and volunteers, and final corrections will be made.
Two groups, the intervention and control groups, will be given a 2-hour theoretical training on the risks of pregnancy and postpartum thromboembolism prepared by the researchers. Then, the "Thromboembolism information evaluation form" will be applied to the intervention and control groups. The control group will not be taught with the simulation method.
After the pilot application, the intervention group will be given a laboratory environment close to the clinical environment and will be given scenarios prepared with simulation method teaching and thromboembolism risk assessment training. The simulation application teaching period is planned to be 45 minutes in total, with the first 10 minutes of preliminary information, 15 minutes of teaching with the simulation method, and the last 20 analysis sessions. Afterwards, the thoughts of each 6 students regarding simulation training and teaching will be evaluated in the analysis sessions. Then, the thromboembolism information form and the two scales to be used will be applied to the Intervention group. It is planned to apply the same application to the intervention group twice in total, with an interval of 2 weeks.
- Conditions
- Simulation, Venous Thromboembolism
- Being tested
- Simulation application
- Keywords
- teaching with simulation, venous thromboembolism during pregnancy, postpartum embolism, midwifery student training
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation applicationOther
Teaching the risk of thromboembolism during pregnancy and postpartum through simulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 3rd grade midwifery students experimental group Diagnostic Information Form and Thromboembolism Information Form were applied before the theory training.
Pregnancy and postpartum thromboembolism theory training was given,
1. st application: Deep vein thrombosis management scenario during pregnancy A high-validity simulation scenario was implemented. Student Satisfaction and Self-Confidence Scale in Learning after the application, Simulation Design Scale implemented
2. nd application: It will be done after 2 weeks. Postpartum Embolism Management Scenario was implemented Student Satisfaction and Self-Confidence Scale in Learning after the application, Simulation Design Scale will be applied. Thromboembolism Information Form - Posttest Done After 2 Weeks After 2 months, Thromboembolism Information Form - Persistence Test was performed. Receives: Other: Simulation application |
| control group | No intervention | 3rd grade midwifery students Control group Diagnostic Information Form and Thromboembolism Information Form were applied before the theory training. Thromboembolism Information Form-Posttest was applied 1 month later. After the Last Test, Thromboembolism Information Form - Persistence Test was applied 2 months later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolism Information Sheet
Thromboembolism Information Sheet,Thromboembolism Information Form is a three-part form consisting of 20 questions. Each question is worth 5 points. (Max:100, Min:0)
Measured: Thromboembolism Information Form - is applied 3 times within 3 months as pre-test, post-test and permanence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start15 May 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimulationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURCAN ÇAĞLAYAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218095
- Sponsor's protocol ID
- PhD Midwifery
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared 6 months after publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Simulation Teaching Efficiency in Evaluation of Thromboembolism Risk in Pregnancy and Postpartum Period
- ClinicalTrials.gov ID
- NCT06218095
- Acronym / sponsor ID
- PhD Midwifery
- Conditions
- Simulation, Venous Thromboembolism
- Keywords
- teaching with simulation, venous thromboembolism during pregnancy, postpartum embolism, midwifery student training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 23 Jan 2024 (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.
This research will be carried out to determine the effectiveness of teaching thromboembolism risk assessment during pregnancy and postpartum period to midwifery students using a high-tech simulation method.
Thromboembolism during pregnancy and postpartum period is one of the preventable causes of maternal deaths. For this reason, it is important to determine the thromboembolism risk of pregnant women and postpartum women by midwives before complications develop and to plan preventive interventions. The aim of the research is to provide midwifery students with the ability to evaluate the risk of thromboembolism before clinical experience through high-tech simulation application.
Goals;
- To increase midwifery students' skills in assessing thromboembolism risk during pregnancy and postpartum period before clinical practice.
- To increase the self-confidence and satisfaction of midwifery students with simulation application in pregnancy and postpartum thromboembolism risk assessment skills.
- To develop midwifery students' quick, critical thinking and decision-making skills in assessing the risk of thromboembolism before clinical practice.
- To help midwifery students visualize the risk of pregnancy and postpartum thromboembolism, which has an important place in terms of maternal deaths, by creating a clinical environment with a case scenario.
- To determine the effectiveness of midwifery teaching through case scenario simulation application with the risk of pregnancy and postpartum thromboembolism, and to increase students' learning and clinical practice skills.
Detailed description
Design of the Research: Researchers will receive scenario creation and simulation design training for the advanced technology simulation method. After the simulation training, pregnancy and postpartum thromboembolism scenarios will be prepared for the intervention group. A thromboembolism information form will be prepared for the intervention and control groups. Expert opinions will be obtained from at least 6 people who are experts in the field of risky pregnancy and postpartum on the forms and scenarios prepared by the researcher. In line with expert opinions, the scenarios and thromboembolism information form will be finalized. The scenarios and forms prepared for the intervention group will be piloted with 6 3rd year midwifery students and volunteers, and final corrections will be made.
Two groups, the intervention and control groups, will be given a 2-hour theoretical training on the risks of pregnancy and postpartum thromboembolism prepared by the researchers. Then, the "Thromboembolism information evaluation form" will be applied to the intervention and control groups. The control group will not be taught with the simulation method.
After the pilot application, the intervention group will be given a laboratory environment close to the clinical environment and will be given scenarios prepared with simulation method teaching and thromboembolism risk assessment training. The simulation application teaching period is planned to be 45 minutes in total, with the first 10 minutes of preliminary information, 15 minutes of teaching with the simulation method, and the last 20 analysis sessions. Afterwards, the thoughts of each 6 students regarding simulation training and teaching will be evaluated in the analysis sessions. Then, the thromboembolism information form and the two scales to be used will be applied to the Intervention group. It is planned to apply the same application to the intervention group twice in total, with an interval of 2 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Simulation application3rd grade midwifery students experimental group Diagnostic Information Form and Thromboembolism Information Form were applied before the theory training. Pregnancy and postpartum thromboembolism theory training was given, 1. st application: Deep vein thrombosis management scenario during pregnancy A high-validity simulation scenario was implemented. Student Satisfaction and Self-Confidence Scale in Learning after the application, Simulation Design Scale implemented 2. nd application: It will be done after 2 weeks. Postpartum Embolism Management Scenario was implemented Student Satisfaction and Self-Confidence Scale in Learning after the application, Simulation Design Scale will be applied. Thromboembolism Information Form - Posttest Done After 2 Weeks After 2 months, Thromboembolism Information Form - Persistence Test was performed. |
| control group | No intervention | –3rd grade midwifery students Control group Diagnostic Information Form and Thromboembolism Information Form were applied before the theory training. Thromboembolism Information Form-Posttest was applied 1 month later. After the Last Test, Thromboembolism Information Form - Persistence Test was applied 2 months later. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Having a statement of consent
- Being a third year midwifery student
- Having taken the risky pregnancy and birth course
Key exclusion criteria (3 listed)
- Wishing to withdraw from the research at any time.
- Not participating in all simulation applications
- Incompletely filling out data collection forms
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 |
|---|---|---|
| Simulation applicationTeaching the risk of thromboembolism during pregnancy and postpartum through simulation | Other | Experimental |
Primary outcome
Thromboembolism Information Sheet
Time frame: Thromboembolism Information Form - is applied 3 times within 3 months as pre-test, post-test and permanence.
Thromboembolism Information Sheet,Thromboembolism Information Form is a three-part form consisting of 20 questions. Each question is worth 5 points. (Max:100, Min:0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No. Data will be shared 6 months after publication.
Related trials for Simulation
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruiting
SELF-ASSESSMENT AND KNOWLEDGE LEVEL OF NURSING STUDENTS' PATIENT SAFETY COMPETENCY
Simulation Training, Nursing Education
RecruitingObservational study
Anomalous Aortic Origin of Coronary Artery
Anomalous Aortic Origin of the Coronary Artery (AAOCA)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation application in people with Simulation and Venous Thromboembolism, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolism Information Sheet (time frame: Thromboembolism Information Form - is applied 3 times within 3 months as pre-test, post-test and permanence.). 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 23 Jan 2024.