Clinical Simulation as a Learning Tool in Medical Students
NCT ID: NCT05269576
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
84 participants
INTERVENTIONAL
2020-09-12
2022-09-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Factors Affecting Medical Student Learning in Simulation Scenarios
NCT01117467
Interprofessional Education of Medical Students Using Medical Simulation
NCT05817682
Virtual Clinical Simulation for Training Amongst Undergraduate Medical Students: A Pilot Randomised Trial
NCT03976388
Debriefing Styles and Clinical Judgment in Nursing Students
NCT07262424
A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students
NCT03071367
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Simulation provides the possibility of scheduling the acquisition of knowledge and skills in a safe environment, in which mistakes have no consequences, at a time and place.
The true learning of the student is significant when there is a reflection and assimilation of what he has learned.
At the Medicine School of Autonomous University of Barcelona (UAB), simulation has begun to be applied as a learning method at different times during the academic year.
The hypothesis of our work is that with the simulation techniques applied in the Medical School of the UAB, students accelerate the learning curve of clinical skills, acquire transversal skills in medicine, and obtain a higher quality learning.
The investigators have designed a prospective and descriptive study, which includes simulation analysis in 3rd year medicine students at the UAB during the academic years 2020/2021 and 2021/2022.
The main objective is to know the effectiveness of simulation in 3rd year medical students, through the objective evaluation of clinical and transversal competences with Mini Clinical Evaluation Exercise (Mini-CEX)
The secondary objectives are:
* To know the effect of clinical care practice in 3rd year medical students
* To compare the effect of simulation with that of clinical practice
* Qualitative analysis of the simulation by analyzing its objectives
* Contrast the evaluation of the objectives between student who did the simulation, observer students and teacher.
* Contrast the evaluation of the objectives between the different cases of each session
* Analysis of emotional interference in the evaluation of objectives
* To evaluate the quality of the clinical simulation
The study consists of analyzing the basic skills of medical students through a Mini Clinical Evaluation Exercise (Mini-CEX), which is carried out in three moments of the academic year:
* At the beginning, where the students have not had any previous experience with clinical practices or simulation.
* In the middle of the course, where there are two groups of students, one that has only done clinical practice and the other that has only done simulation. So an evaluation with Mini-CEX is carried out having performed only one of the two interventions.
* At the end of the course, where all the students have carried out clinical practices and simulation.
In each simulation session, 5 clinical cases are carried out, where the acquisition of the objectives of the simulation session and the emotional state of the student who is performing the simulation in the practical scenario are evaluated.
This evaluation is carried out by means of a questionnaire that is filled out for each of the cases, specifying who fills it out: the student who has carried out the simulation, the observer students or the teacher.
At the end of the simulation period, a satisfaction questionnaire is collected and answered by all the participants to assess the quality of the simulation classes.
Statistical analysis:
Mini-CEX can be evaluated using a scale from 0 to 10 in different domains. The domains are: history, physical examination, professionalism, clinical judgment, communication skills, and organization and efficiency. There is a summary domain that is the examiner's global assessment. This scale can be easily measured using a visual analog scale (VAS), as well as a 10-point Likert scale. To facilitate the power and ease of statistical calculations, the investigators will use the VAS scale as the measurement element.
There is also a categorical option in the Mini-CEX evaluation where the exam can be unsatisfactory, satisfactory or superior.
The objectives of the simulation can be evaluated using a VAS scale from 0 to 10 in different domains and a categorical option between objective achieved, partially achieved and not achieved. The domains are: history, physical examination, doctor-patient relationship and clinical judgment.
The satisfaction questionnaire can be evaluated using a scale from 0 to 5 in different questions.
Quantitative variables will be described as meas and 95% confidence interval. Qualitative variables will be described as percentages and 95% confidence interval.
Comparisons between different means will be made using t student. Comparisons between different percentages will be made using chi squared. Comparisons between different categorical variables will be made using Mantel-Haenszel test. In all cases, the investigators will use an alfa value of 0.05.
To calculate the number of students needed to calculate two means (VAS values between 0 and 10), the investigators assume a standard deviation in both means of 2 with a minimum magnitude of the effect to be detected equal to 1, an alpha error of 0.05 and a beta error of 0.05. from 0.2; the number needed for a bilateral contrast test is 63.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single arm that receive two different interventions (clinical practice and clinical simulation).
An analysis is carried out to the entire group prior to intervention. A second analysis is carried out to the entire group after one of the two interventions. Finally, a last analysis is carried out to the entire group after complete both types of interventions.
We apply the study in a group of medicine students of 3rth course of the degree. We examine their competencies at the beginning of the course. Re-examination is done after they do a period of clinical practice or a period of clinical simulation. At the end of the course, all the students done both interventions (clinical practice and clinical simulation), moment when we do the last examination of their competencies.
Clinical practice
Period of 5 days where medical students carry out hospital clinical practices with real patients supervised by professionals who teach them at the same time.
Clinical simulation
Clinical simulation classes through 2 sessions of 5 simulated cases each day. All students actively participate in one or two of the simulation cases and observed and discussed all the cases in the debriefings of all of them.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical practice
Period of 5 days where medical students carry out hospital clinical practices with real patients supervised by professionals who teach them at the same time.
Clinical simulation
Clinical simulation classes through 2 sessions of 5 simulated cases each day. All students actively participate in one or two of the simulation cases and observed and discussed all the cases in the debriefings of all of them.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Students who have not attended clinical practices or simulation classes
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corporacion Parc Tauli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fernando Martinez-Lopez
MD. Principal investigator. Anesthesiology coordinator.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fernando Martínez-López, MD
Role: PRINCIPAL_INVESTIGATOR
Universitat Autonoma de Barcelona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Autonomous University of Barcelona
Bellaterra, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
McGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med. 2011 Jun;86(6):706-11. doi: 10.1097/ACM.0b013e318217e119.
Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.
Norcini JJ, Blank LL, Duffy FD, Fortna GS. The mini-CEX: a method for assessing clinical skills. Ann Intern Med. 2003 Mar 18;138(6):476-81. doi: 10.7326/0003-4819-138-6-200303180-00012.
Norcini JJ, Blank LL, Arnold GK, Kimball HR. The mini-CEX (clinical evaluation exercise): a preliminary investigation. Ann Intern Med. 1995 Nov 15;123(10):795-9. doi: 10.7326/0003-4819-123-10-199511150-00008.
Norcini JJ, Blank LL, Arnold GK, Kimball HR. Examiner differences in the mini-CEX. Adv Health Sci Educ Theory Pract. 1997;2(1):27-33. doi: 10.1023/A:1009734723651.
Hatala R, Ainslie M, Kassen BO, Mackie I, Roberts JM. Assessing the mini-Clinical Evaluation Exercise in comparison to a national specialty examination. Med Educ. 2006 Oct;40(10):950-6. doi: 10.1111/j.1365-2929.2006.02566.x.
Leblanc VR. Review article: simulation in anesthesia: state of the science and looking forward. Can J Anaesth. 2012 Feb;59(2):193-202. doi: 10.1007/s12630-011-9638-8. Epub 2011 Dec 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FMartinez medical simulation
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.