Volunteers Medical Students in Anesthesiology-intensive CareNCT07663760
Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX
A study testing Behavioral in people with Volunteers Medical Students in Anesthesiology-intensive Care, run by Mongi Slim Hospital.
Trial summary
Modern medical education is based on competency-based learning and the use of formative assessment tools in real clinical settings, such as the Mini-Clinical Evaluation Exercise (mini-CEX). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volunteers Medical Students in Anesthesiology-intensive Care
- What is being tested?
- Behavioral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2026to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fifth-year medical students (DCEM3) enrolled at the Faculty of Medicine of Tunis within the acute medicine program.
- Students completing their clinical clerkship during the second semester of the 2025-2026 academic year in one of the three participating anesthesiology and intensive care departments.
- Students who voluntarily agree to participate and have provided written informed consent.
Who cannot join
- Students who do not complete the entire educational curriculum (absence from either of the two assessments).
- Students who have already received similar training.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX: A Multicenter Study in Anesthesiology and Intensive Care Medicine
Modern medical education is based on competency-based learning and the use of formative assessment tools in real clinical settings, such as the Mini-Clinical Evaluation Exercise (mini-CEX). However, the impact of a prior simulated mini-CEX experience on subsequent performance in real clinical settings remains insufficiently studied, particularly among medical students in anesthesiology-intensive care (DCEM3). This study aimed to assess the effect of a simulated mini-CEX on performance during a real mini-CEX in pre-anesthetic consultation.
Read the detailed description
We conducted a prospective, multicenter interventional study over 4 weeks in three anesthesiology-intensive care departments in Tunis. Volunteer DCEM3 students were assessed by trained anesthesiology faculty using the mini-CEX tool. The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter. Performance was evaluated using a 7-domain mini-CEX checklist, including direct observation, scoring, and immediate formative feedback. The primary outcome was the overall mini-CEX score. Secondary outcomes included domain-specific scores, inter-rater reliability, individual progression, and participant satisfaction.
- Being tested
- Behavioral
- Keywords
- Competence, Medical education, Anesthesiology, Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralOther
Also called Simulated Mini-CEX, Mini-CEX-based educational intervention
Mini-CEX educational assessment during pre-anesthetic consultation: Volunteer fifth-year medical students were assessed by trained anesthesiology faculty using the mini-CEX tool. The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter.
| Study group | Role | What they receive |
|---|---|---|
| DCEM3 students | Experimental | Fifth-year medical students in the second cycle during their internship in anesthesiology and intensive care. Receives: Other: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
students' overall performance
measured by the mean score on the Mini-CEX checklist, compared between simulated consultation and real consultation.
The overall performance is assessed using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX) checklist. The global score is measured on a 9-point Likert scale, ranging from 1 (insufficient/unsatisfactory performance) to 9 (exceptional/exemplary performance). Higher scores indicate a better clinical performance and greater student autonomy.
Measured: Through study completion, up to 4 weeks
Secondary outcomes (5)
Scores for each domain
Scores for each domain (history taking, physical examination, clinical judgment, communication skills, professionalism, organization and efficiency, and overall clinical performance). Measured by the Mini-Clinical Evaluation Exercise (Mini-CEX) checklist, compared between the simulated consultation (baseline) and the real clinical consultation. The checklist uses a 9-point Likert scale where 1 represents the lowest performance (insufficient) and 9 represents the highest performance (exceptional). Higher scores indicate a better clinical outcome.
Measured: at the and of each Mini-CEX , Through study completion, up to 4 weeks
Inter-rater reproducibility of Mini-CEX
Inter-rater reproducibility was evaluated using the Intraclass Correlation Coefficient (ICC
Measured: at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
Individual performance gain
Individual performance gain (delta between simulated and real Mini-CEX scores) Calculated as the change score between the real clinical consultation and the simulated consultation (Real score minus Simulated score) using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX). The original Mini-CEX scale ranges from a minimum value of 1 (insufficient performance) to a maximum value of 9 (exceptional performance). The resulting performance gain score ranges from -8 to +8. A higher or positive score indicates a better outcome (improvement/performance gain), a score of 0 indicates no change, and a negative score indicates a decrease in performance.
Measured: at the end of the internship, Through study completion, up to 4 weeks
Learner and faculty satisfaction
Learner and faculty satisfaction, as well as their recommendation for the use of the Mini-CEX throughout the curriculum, assessed using a Likert scale. Assessed via a post-internship questionnaire completed by both students (learners) and professors (faculty) regarding their satisfaction with the Mini-Clinical Evaluation Exercise (Mini-CEX) and their recommendation for its integration throughout the curriculum. Responses are evaluated on a 5-point Likert scale, ranging from a minimum score of 1 (Strongly disagree / Very dissatisfied) to a maximum score of 5 (Strongly agree / Very satisfied). Higher scores indicate a better outcome, representing higher levels of satisfaction and a stronger recommendation for curriculum implementation.
Measured: at the end of internship, Through study completion, up to 4 weeks
The time required to complete the consultation
The time required to complete the consultation (measured in minutes)
Measured: at the end of each Mini-Cex, Through study completion, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start2 Jun 2026 (estimated)
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volunteers Medical Students in Anesthesiology-intensive CareStudies 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
- Model description
- Volunteer DCEM3 students were assessed by trained anesthesiology faculty using the mini-CEX tool. The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter. Performance was evaluated using a 7-domain mini-CEX checklist, including direct observation, scoring, and immediate formative feedback.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663760
- Sponsor's protocol ID
- Simulated mini-CEX
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX: A Multicenter Study in Anesthesiology and Intensive Care Medicine
- ClinicalTrials.gov ID
- NCT07663760
- Acronym / sponsor ID
- Simulated mini-CEX
- Keywords
- Competence, Medical education, Anesthesiology, Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 2 Jun 2026 (estimated)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 23 Jun 2026 (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.
Modern medical education is based on competency-based learning and the use of formative assessment tools in real clinical settings, such as the Mini-Clinical Evaluation Exercise (mini-CEX). However, the impact of a prior simulated mini-CEX experience on subsequent performance in real clinical settings remains insufficiently studied, particularly among medical students in anesthesiology-intensive care (DCEM3). This study aimed to assess the effect of a simulated mini-CEX on performance during a real mini-CEX in pre-anesthetic consultation.
Detailed description
We conducted a prospective, multicenter interventional study over 4 weeks in three anesthesiology-intensive care departments in Tunis. Volunteer DCEM3 students were assessed by trained anesthesiology faculty using the mini-CEX tool. The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter. Performance was evaluated using a 7-domain mini-CEX checklist, including direct observation, scoring, and immediate formative feedback. The primary outcome was the overall mini-CEX score. Secondary outcomes included domain-specific scores, inter-rater reliability, individual progression, and participant satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Volunteer DCEM3 students were assessed by trained anesthesiology faculty using the mini-CEX tool. The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter. Performance was evaluated using a 7-domain mini-CEX checklist, including direct observation, scoring, and immediate formative feedback.
| Arm | Type | Receives |
|---|---|---|
| DCEM3 students | Experimental | Other: BehavioralFifth-year medical students in the second cycle during their internship in anesthesiology and intensive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fifth-year medical students (DCEM3) enrolled at the Faculty of Medicine of Tunis within the acute medicine program.
- Students completing their clinical clerkship during the second semester of the 2025-2026 academic year in one of the three participating anesthesiology and intensive care departments.
- Students who voluntarily agree to participate and have provided written informed consent.
Key exclusion criteria (2 listed)
- Students who do not complete the entire educational curriculum (absence from either of the two assessments).
- Students who have already received similar training.
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 |
|---|---|---|
| BehavioralAlso: Simulated Mini-CEX, Mini-CEX-based educational interventionMini-CEX educational assessment during pre-anesthetic consultation: Volunteer fifth-year medical students were assessed by trained anesthesiology faculty using the mini-CEX tool. The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter. | Other | DCEM3 students |
Primary outcome
students' overall performance
Time frame: Through study completion, up to 4 weeks
measured by the mean score on the Mini-CEX checklist, compared between simulated consultation and real consultation. The overall performance is assessed using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX) checklist. The global score is measured on a 9-point Likert scale, ranging from 1 (insufficient/unsatisfactory performance) to 9 (exceptional/exemplary performance). Higher scores indicate a better clinical performance and greater student autonomy.
5 secondary outcomes
Scores for each domain
Time frame: at the and of each Mini-CEX , Through study completion, up to 4 weeks
Inter-rater reproducibility of Mini-CEX
Time frame: at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
Individual performance gain
Time frame: at the end of the internship, Through study completion, up to 4 weeks
Learner and faculty satisfaction
Time frame: at the end of internship, Through study completion, up to 4 weeks
The time required to complete the consultation
Time frame: at the end of each Mini-Cex, Through study completion, up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral in people with Volunteers Medical Students in Anesthesiology-intensive Care, run by Mongi Slim Hospital.
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 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Sami Mebazaa, professor (22252589 ext. 00216, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
students' overall performance (time frame: Through study completion, up to 4 weeks). 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 23 Jun 2026.