- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05817682
Interprofessional Education of Medical Students Using Medical Simulation
April 16, 2023 updated by: Barbara Siekierska, Andrzej Frycz Modrzewski Krakow University
Due to the growing role of medical simulation in the education of medical students and the development of cooperation in interdisciplinary teams in the health care sector, a study was designed to examine the relationship between the competences and resources of students and the role of education through simulation classes based on the development of technical and in cooperation with specialists in these fields.
Researchers want to focus on students' levels of stress and anxiety, coping strategies, and self-efficacy.
An important element will be the self-assessment of students on the level of their non-technical competences.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- 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
-
-
-
Kraków, Poland, 30-705
- Andrzej Frycz Modrzewski Krakow University
-
-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Voluntary consent to participate in the study
- Declaration of participation in the Interdisciplinary Simulation Circle
- Student status in the field of medicine (6th year) or nursing (3rd year of first-cycle studies) or medical rescue (3rd year)
Exclusion Criteria:
- Completed another course of medical studies
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Intervention group
|
The study will be conducted among students of the Krakow Academy. The experimental group will consist of 35 students participating in the Interdisciplinary Circle of Medical Simulation from the following faculties: medicine, nursing and medical rescue. Students will be divided into 7 interprofessional teams, in which they will take classes planned for small groups. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the ongoing interprofessional education
Time Frame: 10 months
|
1.
A self - report questionnaire including a socio-demographic data sheet and questions regarding the motivation for choosing the field of study, as well as a form for the ongoing evaluation of Interdisciplinary Club classes to be completed before and after classes.
|
10 months
|
|
Evaluation of the impact of interprofessional education on soft-skill development
Time Frame: 10 months
|
1. Self-assessment form in the field of soft skills - own study, which contains 17 statements describing soft skills in an interprofessional team.
Respondents assess their development on a five-point Likert scale, where "1" means "I completely disagree" and "5" - "I completely agree".
|
10 months
|
|
Evaluation of the impact of interprofessional education using the simulation method on self-efficacy.
Time Frame: 10 months
|
1. General Self-Efficacy Scale (GSE) with the total score calculated by finding the sum of all the items and ranges between 10 and 40, with higher score indicating more self-efficacy.
|
10 months
|
|
Evaluation of the impact of interprofessional education using the simulation method on student stress level.
Time Frame: 10 month
|
A 10-item Perceived Stress Scale (PSS-10) for assessing how often a respondent thought and felt in the given way in the last month using a five-point Likert scale.
The result of the measurement is the stress severity index.
The PSS score is obtained by summing across all items.
Higher scores indicate higher levels of perceived stress.
|
10 month
|
|
Evaluation of the impact of interprofessional education using the simulation method on stress coping.
Time Frame: 10 month
|
The Stress Coping Inventory (Mini COPE).
The respondent determines how often he/she acts in the described way when experiencing a stressful situation using a four-point Likert scale (0-I almost never do that, 1-I rarely do that, 2-I often do that, 3-I almost always do that).
Every statement is assigned to one of 14 stress-coping categories.
|
10 month
|
|
Evaluation of the impact of interprofessional education using the simulation method on perception of medical professions.
Time Frame: 10 month
|
Word Cloud - own study - a form used to assess the mutual perception of medical professions in an interprofessional team.
The respondents choose five terms from the proposed word database.
|
10 month
|
|
Evaluation of the impact of interprofessional education using the simulation method on students anxiety.
Time Frame: 10 month
|
A 20-item State-Trait Anxiety Inventory (STAI) for assessing trait anxiety and 20 for state anxiety.
All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always").
Higher scores indicate greater anxiety.
|
10 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 20, 2022
Primary Completion (Anticipated)
June 15, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
March 5, 2023
First Submitted That Met QC Criteria
April 16, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 16, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- WLNZ/NoZ/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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