- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02776358
HFS in the Assessement and Management of Severe Asthma Attack Among Fifth Year Medical School Students (SimAG)
High Fidelity Simulation (HFS) Versus Video-case(VC) Trainings in the Assessement and Management of Severe Asthma Attack Among Medical School Students: a Randomized Controlled Study
Bedside clinical case learning, such for respiratory distress, represent a challenge for medical teachers, especially in critical conditions. In fact, this kind of learning implicate the presence of an appropriate case (the patient itself), framework and may be time consuming which could compromise the patient's safety and wellbeing.
New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of knowledge. in recent years, the development of medical simulation has found a growing interest in the medical teaching field. Contextualization, reproducibility and reliability are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime experience of clinical conditions without putting at risk patient's safety and comfort.
The aim of this study is to assess the impact of HFS on fifth year medical students learning skills in the assessement and management of an acute asthma attack in the emergency room, and to compares it to other modern teaching tools such as "video-case"
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Monastir, Tunisia, 5000
- University of Monastir
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all fifth year medical students allocated to the one month internship period in the emergency departement.
Exclusion Criteria:
- students refusing to participate in the protocol.
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Fidelity Simulation
Students will receive a 1 hour High fidelity simulation session
|
A HFS session for an asthma attack require:
A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course. Also, another test will be done after 7 days of the course. |
|
Experimental: Video Case
Students will receive a 1 hour assisted Video Case learning session
|
a video case (or video box) session in which students will attend a video-projection of a real case of an asthma attack and discuss with the trainer the different steps of the assessement and management of an asthma attack. A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course. Also, another test will be done after 7 days of the course. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference between the pre and the post-test scores in each group (delta Score)
Time Frame: Just before the teaching course (baseline) and one hour later
|
The difference between the pre and the post-test scores is calculated as follow: delta score = post-test score - pre-test score |
Just before the teaching course (baseline) and one hour later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Late performance score
Time Frame: 7 days after the teaching course
|
This score is calculated based on a test taken 7 days after the teaching course to assess the students memory of the clinical case and acquired knowledge.
|
7 days after the teaching course
|
|
Level of satisfaction
Time Frame: one hour after the teaching course
|
A five point likert scale is given to each student to assess their level of satisfaction regarding the teaching technique.
|
one hour after the teaching course
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed habib Grissa, MD, Emergency Department , university hospital of Monastir, TUNISIA
- Principal Investigator: Nouira Semir, Professor, Emergency Department , university hospital of Monastir, TUNISIA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SimAG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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