SimulationNCT05269576
Clinical Simulation as a Learning Tool in Medical Students
A study testing Clinical practice and Clinical simulation in people with Simulation and Students, Medical, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simulation, Students, Medical, Feedback
- What is being tested?
- Clinical practice and Clinical simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2020to 22 Sep 2022
- 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
- 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.
Who cannot join
- Students with prior experience in hospital clinical practice or clinical simulation
- Students who have not attended clinical practices or simulation classes
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Autonomous University of Barcelona
Bellaterra, Barcelona, 08193
Fernando Martínez-López, MD, +34937231010 ext. 21277, fmartinezlo1969@gmail.com
Sandra Montmany-Vioque, phD, MD, +34937231010 ext. 21490, sandra.montmany@gmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Simulation, Students, Medical, Feedback, Competency-based Education, Learning
- Being tested
- Clinical practice, Clinical simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical practiceOther
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 simulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm that receive two different interventions (clinical practice and clinical simulation). | Experimental | 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. Receives: Other: Clinical practice; Other: Clinical simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: Through study completion, an average of 6 months.
Secondary outcomes (10)
To know the effect of clinical care practice in 3rd year medical students
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.
Measured: Through study completion, an average of 6 months.
To compare the effect of simulation with that of clinical practice
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.
Measured: Through study completion, an average of 6 months.
Qualitative analysis of the simulation by analyzing its objectives by questionnaire
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.
Measured: 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
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.
Measured: Through study completion, an average of 6 months.
Contrast the evaluation of the objectives between the different cases of each session by questionnare
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.
Measured: Through study completion, an average of 6 months.
Analysis of emotional interference in the evaluation of objectives by visual analog scale
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.
Measured: Through study completion, an average of 6 months.
To evaluate the quality of the clinical simulation
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).
Measured: Through study completion, an average of 6 months.
Numerical analysis of the simulation by analyzing its objectives by visual analog scale
Numerical evaluation with a visual analog scale from 0 to 10 for every teaching objective.
Measured: 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
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.
Measured: 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
Numerical evaluation with a visual analog scale from 0 to 10 for every teaching objective in each case of the session of simulation.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start12 Sep 2020
- Primary completion22 Jun 2022 (estimated)
- Study completion22 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SimulationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Martinez-Lopez, Corporacion Parc Tauli
- Investigators
- Fernando Martínez-López, MD, Principal investigator, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269576
- Sponsor's protocol ID
- FMartinez medical simulation
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 21512370Cook 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.
PubMed 21900138Norcini 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.
PubMed 12639081Norcini 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.
PubMed 7574198Norcini 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.
PubMed 16180056Hatala 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.
PubMed 16987184Leblanc 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.
PubMed 22179792
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Simulation as a Learning Tool in Medical Students
- ClinicalTrials.gov ID
- NCT05269576
- Acronym / sponsor ID
- FMartinez medical simulation
- Conditions
- Simulation, Students, Medical, Feedback, Competency-based Education, Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 22 Jun 2022 (estimated)
- Study completion
- 22 Sep 2022 (estimated)
- First posted
- 8 Mar 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm that receive two different interventions (clinical practice and clinical simulation). | Experimental | Other: Clinical practice, Other: Clinical simulationAn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Students with prior experience in hospital clinical practice or clinical simulation
- Students who have not attended clinical practices or simulation classes
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 |
|---|---|---|
| Clinical practicePeriod of 5 days where medical students carry out hospital clinical practices with real patients supervised by professionals who teach them at the same time. | Other | Single arm that receive two different interventions (clinical practice and clinical simulation). |
| Clinical simulationClinical 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. | Other | Single arm that receive two different interventions (clinical practice and clinical simulation). |
Primary outcome
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)
Time frame: 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.
10 secondary outcomes
To know the effect of clinical care practice in 3rd year medical students
Time frame: Through study completion, an average of 6 months.
To compare the effect of simulation with that of clinical practice
Time frame: Through study completion, an average of 6 months.
Qualitative analysis of the simulation by analyzing its objectives by questionnaire
Time frame: 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
Time frame: Through study completion, an average of 6 months.
Contrast the evaluation of the objectives between the different cases of each session by questionnare
Time frame: Through study completion, an average of 6 months.
Analysis of emotional interference in the evaluation of objectives by visual analog scale
Time frame: Through study completion, an average of 6 months.
To evaluate the quality of the clinical simulation
Time frame: Through study completion, an average of 6 months.
Numerical analysis of the simulation by analyzing its objectives by visual analog scale
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Results publication: PubMed 21512370McGaghie 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.
- Results publication: PubMed 21900138Cook 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.
- Results publication: PubMed 12639081Norcini 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.
- Results publication: PubMed 7574198Norcini 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.
- Results publication: PubMed 16180056Norcini 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.
- Results publication: PubMed 16987184Hatala 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.
- Results publication: PubMed 22179792Leblanc 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.
- Individual participant dataSharing planned: No. 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.
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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.
Fernando Martínez-López, MD principal investigator
Universitat Autonoma de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical practice and Clinical simulation in people with Simulation and Students, Medical, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 2 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 22 Mar 2022. 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 Spain. 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?
Contact Fernando Martínez-López, MD (+34937231010 ext. 21277, fmartinezlo1969@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05269576, which also lists 7 linked publications.
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 22 Mar 2022.