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

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.

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.
62

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

  • Poland
      • 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

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

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

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.
No Intervention: Control group
Experimental: Intervention group
Other: Interprofessional education

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

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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Andrzej Frycz Modrzewski Krakow University

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.
October 20, 2022

Primary Completion (Anticipated)

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 15, 2023

Study Completion (Anticipated)

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.
September 30, 2023

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).
March 5, 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.
April 16, 2023

First Posted (Actual)

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.
April 18, 2023

Study Record Updates

Last Update Posted (Actual)

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.
April 18, 2023

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.
April 16, 2023

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, 2023

More Information

Terms related to this study

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.
  • 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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