Pregnancy and Postpartum Period Venous Thromboembolism and Simulation

January 11, 2024 updated by: NURCAN ÇAĞLAYAN, Saglik Bilimleri Universitesi

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34668
        • University of Health Sciences Midwifery Simulation Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having a statement of consent
  • Being a third year midwifery student
  • Having taken the risky pregnancy and birth course

Exclusion Criteria:

  • Wishing to withdraw from the research at any time.
  • Not participating in all simulation applications
  • Incompletely filling out data collection forms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Simulation application
Teaching the risk of thromboembolism during pregnancy and postpartum through simulation
No Intervention: control group

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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Thromboembolism Information Form - is applied 3 times within 3 months as pre-test, post-test and permanence.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PhD midwifery (Registry Identifier: GulhaneSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared 6 months after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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