Medical StudentsNCT05817682
Interprofessional Education of Medical Students Using Medical Simulation
A study testing Interprofessional education in people with Medical Students, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Students
- What is being tested?
- Interprofessional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 20 Oct 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Completed another course of medical studies
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Medical Students
- Being tested
- Interprofessional education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interprofessional educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Interprofessional education |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the ongoing interprofessional education
- 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.
Measured: 10 months
Evaluation of the impact of interprofessional education on soft-skill development
- 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".
Measured: 10 months
Evaluation of the impact of interprofessional education using the simulation method on self-efficacy.
- 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.
Measured: 10 months
Evaluation of the impact of interprofessional education using the simulation method on student stress level.
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.
Measured: 10 month
Evaluation of the impact of interprofessional education using the simulation method on stress coping.
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.
Measured: 10 month
Evaluation of the impact of interprofessional education using the simulation method on perception of medical professions.
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.
Measured: 10 month
Evaluation of the impact of interprofessional education using the simulation method on students anxiety.
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.
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Oct 2022
- Primary completion15 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Siekierska, Andrzej Frycz Modrzewski Krakow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817682
- Sponsor's protocol ID
- WLNZ/NoZ/2022
- Status last verified
- Jan 2023
- First submitted
- 5 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Education of Medical Students Using Medical Simulation
- ClinicalTrials.gov ID
- NCT05817682
- Acronym / sponsor ID
- WLNZ/NoZ/2022
- Conditions
- Medical Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Interprofessional education |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Completed another course of medical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interprofessional educationThe 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. | Other | Intervention group |
Primary outcome
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.
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".
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interprofessional education in people with Medical Students, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the ongoing interprofessional education (time frame: 10 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.