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Clinical Simulation as a Learning Tool in Medical Students

7 marzo 2022 aggiornato da: Fernando Martinez-Lopez, Corporacion Parc Tauli
The hypothesis of our work is that with the simulation techniques applied in the Medical School of the Autonomous University of Barcelona (UAB), students accelerate the learning curve of clinical skills, acquire transversal skills in medicine, and obtain a higher quality learning.

Panoramica dello studio

Descrizione dettagliata

Learning through simulation lies in the recreation of a clinical event, skills or techniques in the most reliable way in order to ensure a much more active experiential learning method than the traditional one built through theoretical classes.

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

84

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Barcelona
      • Bellaterra, Barcelona, Spagna, 08193
        • Reclutamento
        • Autonomous University of Barcelona
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

- Students in the 3rd year of medicine at the UAB (Autonomous University of Barcelona) who, at the beginning of the study, have not carried out any type of hospital clinical practice or clinical simulation.

Exclusion Criteria:

  • Students with prior experience in hospital clinical practice or clinical simulation
  • Students who have not attended clinical practices or simulation classes

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

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 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: Through study completion, an average of 6 months.
Evaluation of competencies through Mini-CEX, which is done in 3 different moments of each course: at the beginning; after clinicar care practice or simulation session; and at the end of the course after clinical care practice and simulation session.
Through study completion, an average of 6 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To know the effect of clinical care practice in 3rd year medical students
Lasso di tempo: Through study completion, an average of 6 months.
Evaluation of competencies through Mini-CEX, which is done in 3 different moments of each course: at the beginning; after clinicar care practice or simulation session; and at the end of the course after clinical care practice and simulation session.
Through study completion, an average of 6 months.
To compare the effect of simulation with that of clinical practice
Lasso di tempo: Through study completion, an average of 6 months.
Evaluation of competencies through Mini-CEX, which is done in 3 different moments of each course: at the beginning; after clinicar care practice or simulation session; and at the end of the course after clinical care practice and simulation session.
Through study completion, an average of 6 months.
Qualitative analysis of the simulation by analyzing its objectives by questionnaire
Lasso di tempo: Through study completion, an average of 6 months.
Questionnaire to assess the achievement of the objectives of the simulation sessions (medical history, physical examination, doctor-patient relationship and correct diagnosis) and the emotional state of the participant in the scenario of simulation (nervousness and comfort). In each simulation session, we evaluated each case with this questionnaire that had to be answered by the student who did the simulation, the observer students and the teacher. The questionnaire had a categorical evaluation (achieved, partially achieved or non achieved) for every teaching objective.
Through study completion, an average of 6 months.
Contrast the evaluation of the objectives between student who did the simulation, observer students and teacher, by questionnaire
Lasso di tempo: Through study completion, an average of 6 months.
Questionnaire to assess the achievement of the objectives of the simulation sessions (medical history, physical examination, doctor-patient relationship and correct diagnosis) and the emotional state of the participant in the scenario of simulation (nervousness and comfort). In each simulation session, we evaluated each case with this questionnaire that had to be answered by the student who did the simulation, the observer students and the teacher. The questionnaire had a categorical evaluation (achieved, partially achieved or non achieved) for every teaching objective.
Through study completion, an average of 6 months.
Contrast the evaluation of the objectives between the different cases of each session by questionnare
Lasso di tempo: Through study completion, an average of 6 months.
Questionnaire to assess the achievement of the objectives of the simulation sessions (medical history, physical examination, doctor-patient relationship and correct diagnosis) and the emotional state of the participant in the scenario of simulation (nervousness and comfort). In each simulation session, we evaluated each case with this questionnaire that had to be answered by the student who did the simulation, the observer students and the teacher. The questionnaire had a categorical evaluation (achieved, partially achieved or non achieved) for every teaching objective; and a numerical evaluation with a visual analog scale from 0 to 10 for every teaching objective and the emotional state.
Through study completion, an average of 6 months.
Analysis of emotional interference in the evaluation of objectives by visual analog scale
Lasso di tempo: Through study completion, an average of 6 months.
The emotional state of the participant in the scenario of simulation (nervousness and comfort) was evaluated in each case with a numerical evaluation by a visual analog scale from 0 to 10. VSA had to be answered by the student who did the simulation, the observer students and the teacher.
Through study completion, an average of 6 months.
To evaluate the quality of the clinical simulation
Lasso di tempo: Through study completion, an average of 6 months.
Quality and satisfaction survey of the clinical simulation carried out by the participants at the end of the simulation. The investigators used a validated survey with 11 questions evaluated numerically from 1 to 5 (1 very disagree and 5 very agree).
Through study completion, an average of 6 months.
Numerical analysis of the simulation by analyzing its objectives by visual analog scale
Lasso di tempo: Through study completion, an average of 6 months.
Numerical evaluation with a visual analog scale from 0 to 10 for every teaching objective.
Through study completion, an average of 6 months.
Contrast the evaluation of the objectives between student who did the simulation, observer students and teacher, by visual analog scale
Lasso di tempo: Through study completion, an average of 6 months.
Numerical evaluation with a visual analog scale from 0 to 10 for every teaching objective by the student who did the simulation, the observer students and the teacher.
Through study completion, an average of 6 months.
Contrast the evaluation of the objectives between the different cases of each session by visual analog scale
Lasso di tempo: Through study completion, an average of 6 months.
Numerical evaluation with a visual analog scale from 0 to 10 for every teaching objective in each case of the session of simulation.
Through study completion, an average of 6 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Fernando Martínez-López, MD, Universitat Autonoma de Barcelona

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 settembre 2020

Completamento primario (Anticipato)

22 giugno 2022

Completamento dello studio (Anticipato)

22 settembre 2022

Date di iscrizione allo studio

Primo inviato

13 febbraio 2022

Primo inviato che soddisfa i criteri di controllo qualità

25 febbraio 2022

Primo Inserito (Effettivo)

8 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • FMartinez medical simulation

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

At the moment, there is no project to share the study data. We are open to doing it so as soon as we see possibilities of working together with other similar groups.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Clinical practice

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