Equivalence Study Comparing a Cost-Effective PC-Based Ultrasound Training Tool to Traditional Simulators in Third-Year Medical Students
Evaluating the Efficacy of a Cost-Effective PC-Based Tool as a Non-Inferior Alternative to Traditional Ultrasound Simulators in Medical Education
1 other identifier
interventional
408
1 country
1
Brief Summary
Brief Summary: The goal of this clinical trial is to determine if a cost-effective, PC-based ultrasound training tool is as effective as a traditional, medium-cost ultrasound simulator for teaching third-year medical students thoracic and abdominal ultrasound skills. This study focuses on improving access to high-quality ultrasound training in educational settings with limited resources. The main questions it aims to answer are:
- 1.Does the PC-based tool help participants improve their ability to optimize ultrasound images in a way comparable to the traditional simulator?
- 2.Can participants using the PC-based tool identify and interpret pathological conditions with the same accuracy as those using the traditional simulator?
- 3.Watch educational videos covering key concepts in thoracic and abdominal ultrasound imaging.
- 4.Rotate through training stations where they will practice using either the PC-based tool or the traditional simulator.
- 5.Perform hands-on exercises with healthy volunteers to practice image acquisition and recognition of anatomical structures.
- 6.Complete pre- and post-training assessments to measure their progress in skills such as image optimization and identifying pathological conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2024
CompletedFirst Submitted
Initial submission to the registry
January 9, 2025
CompletedFirst Posted
Study publicly available on registry
January 15, 2025
CompletedJanuary 16, 2025
January 1, 2025
2 months
January 9, 2025
January 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement in Image Optimization Skills
Change in the Objective Structured Assessment of Ultrasound Skills (OSAUS) scores for image optimization pre- and post-training.
Measured immediately before and after the training session.
Pathology Recognition Accuracy
Change in the ability to identify and interpret pathological ultrasound images, scored on a scale of 0-3 (0 = no recognition, 3 = full recognition).
Measured immediately before and after the training session.
Secondary Outcomes (2)
Participant Satisfaction with Training
Measured immediately after the training session.
Time Required for Image Acquisition
Measured immediately before and after the training session.
Study Arms (2)
Simulator Thoracic and Abdominal
ACTIVE COMPARATORParticipants in this group will receive ultrasound training using a traditional, medium-cost ultrasound simulator (VausSim). This simulator allows students to practice image acquisition and pathology recognition in a controlled environment. Training will also include hands-on practice with healthy volunteers. The performance of students in this group will be compared to those using the PC-based tool to determine if both methods produce similar learning outcomes.
PC-based tool
EXPERIMENTALParticipants in this group will receive ultrasound training using an interactive PC-based tool. This tool provides real ultrasound images and videos to simulate pathology recognition and image optimization. Students will rotate through different training stations, including hands-on practice with healthy volunteers. The goal is to assess whether this low-cost digital tool is as effective as a traditional ultrasound simulator for teaching ultrasound skills.
Interventions
An interactive, PowerPoint-based PC tool designed to simulate pathology recognition and ultrasound image optimization for medical students. It provides real ultrasound videos and images, allowing students to practice diagnostic interpretation and image acquisition in a structured training format.
A medium-cost ultrasound simulator used for hands-on training in thoracic and abdominal ultrasound. It allows medical students to practice probe handling, image acquisition, and pathology recognition in a controlled simulation environment.
Eligibility Criteria
You may qualify if:
- Third-year medical students enrolled in the "Approach to Ultrasound" internship.
- Participants who have completed the preliminary blended learning videos on thoracic and abdominal ultrasound techniques.
- Participants with or without prior minimal experience in using an ultrasound probe, provided they have not undergone formal specialized ultrasound training.
You may not qualify if:
- Inability to attend all training sessions and assessments as per the study schedule.
- Physical or medical conditions that limit the ability to perform hands-on ultrasound practice (e.g., musculoskeletal injuries).
- Refusal to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SimTo Advanced Medical Simulation Centre
Turin, Italy, Piedmont, 10124, Italy
Related Publications (4)
Kollmann C, Flor M, Bader R. A web-based modern ultrasound diagnostic scanner simulation (SimulUS) for undergraduate medical e-learning education. Med Ultrason. 2016 Sep;18(3):408-9. doi: 10.11152/mu.2013.2066.183.kol. No abstract available.
PMID: 27622424BACKGROUNDWeimer J, Recker F, Hasenburg A, Buggenhagen H, Karbach K, Beer L, Weimer A, Schiestl L, Lorenz L, Kloeckner R, Dionysopoulou A. Development and evaluation of a "simulator-based" ultrasound training program for university teaching in obstetrics and gynecology-the prospective GynSim study. Front Med (Lausanne). 2024 Apr 24;11:1371141. doi: 10.3389/fmed.2024.1371141. eCollection 2024.
PMID: 38721350BACKGROUNDPezel T, Dreyfus J, Mouhat B, Thebaut C, Audureau E, Bernard A, Badie YL, Bohbot Y, Fard D, Nguyen LS, Monteil C, Biere L, Le Ven F, Canu M, Ribeyrolles S, Mion B, Bazire B, Fauvel C, Cautela J, Cambet T, Le Tourneau T, Donal E, Lafitte S, Magne J, Mansencal N, Coisne A; SIMULATOR investigators. Effectiveness of Simulation-Based Training on Transesophageal Echocardiography Learning: The SIMULATOR Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):248-256. doi: 10.1001/jamacardio.2022.5016.
PMID: 37070491BACKGROUNDDamewood S, Jeanmonod D, Cadigan B. Comparison of a multimedia simulator to a human model for teaching FAST exam image interpretation and image acquisition. Acad Emerg Med. 2011 Apr;18(4):413-9. doi: 10.1111/j.1553-2712.2011.01037.x.
PMID: 21496145BACKGROUND
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Research Technician
Study Record Dates
First Submitted
January 9, 2025
First Posted
January 15, 2025
Study Start
March 4, 2024
Primary Completion
April 25, 2024
Study Completion
April 26, 2024
Last Updated
January 16, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
The individual participant data (IPD) from this study will not be shared at this time because additional analyses and follow-up studies are currently in progress. Future research will further explore the implications of the findings, and data sharing may be reconsidered once all related studies are completed and published