Pregnancy and Postpartum Period Venous Thromboembolism and Simulation

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: Active, not recruiting
• Conditions: Venous Thromboembolism; Simulation
• Intervention / Treatment: Other: Simulation application

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: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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,; 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; 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

Outcome Measure	Measure Description	Time Frame
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)	Thromboembolism Information Form - is applied 3 times within 3 months as pre-test, post-test and permanence.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 10, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Estimated): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: teaching with simulation; venous thromboembolism during pregnancy; postpartum embolism; midwifery student training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID 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