NCT06218095

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

December 28, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

teaching with simulationvenous thromboembolism during pregnancypostpartum embolismmidwifery student training

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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

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.

Interventions

Teaching the risk of thromboembolism during pregnancy and postpartum through simulation

Experimental

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Midwifery Simulation Laboratory

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Midwifery

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 23, 2024

Study Start

May 15, 2023

Primary Completion

June 30, 2024

Study Completion

August 10, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Data will be shared 6 months after publication.

Locations