NCT02776358

Brief Summary

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"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 asthma

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

May 4, 2016

Last Update Submit

May 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference between the pre and the post-test scores in each group (delta Score)

    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 Outcomes (2)

  • Late performance score

    7 days after the teaching course

  • Level of satisfaction

    one hour after the teaching course

Study Arms (2)

High Fidelity Simulation

EXPERIMENTAL

Students will receive a 1 hour High fidelity simulation session

Other: High Fidelity Simulation

Video Case

EXPERIMENTAL

Students will receive a 1 hour assisted Video Case learning session

Other: Video case

Interventions

A HFS session for an asthma attack require: * a 5 minutes briefing session: case and equipments presentation and choice of participants * 15 minutes of actual simulation * 40 minutes of debriefing 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.

High Fidelity Simulation

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.

Video Case

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all fifth year medical students allocated to the one month internship period in the emergency departement.

You may not qualify if:

  • students refusing to participate in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

Location

Related Publications (1)

  • Grissa MH, Dhaoui R, Bel Haj Ali K, Sekma A, Toumia M, Sassi S, Sakly AK, Zorgati A, Bouraoui H, Ben Soltane H, Mezgar Z, Boukef R, Boubaker H, Bouida W, Beltaief K, Nouira S. Comparison of simulation and video-based training for acute asthma. BMC Med Educ. 2023 Nov 16;23(1):873. doi: 10.1186/s12909-023-04836-7.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mohamed habib Grissa, MD

    Emergency Department , university hospital of Monastir, TUNISIA

    PRINCIPAL INVESTIGATOR
  • Nouira Semir, Professor

    Emergency Department , university hospital of Monastir, TUNISIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 18, 2016

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations