Equivalence Study Comparing a Cost-Effective PC-Based Ultrasound Training Tool to Traditional Simulators in Third-Year Medical Students

January 14, 2025 updated by: Samuel Agostino, University of Turin, Italy

Evaluating the Efficacy of a Cost-Effective PC-Based Tool as a Non-Inferior Alternative to Traditional Ultrasound Simulators in Medical Education

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?

Participants are third-year medical students enrolled in a structured internship. They will:

  1. Watch educational videos covering key concepts in thoracic and abdominal ultrasound imaging.
  2. Rotate through training stations where they will practice using either the PC-based tool or the traditional simulator.
  3. Perform hands-on exercises with healthy volunteers to practice image acquisition and recognition of anatomical structures.
  4. Complete pre- and post-training assessments to measure their progress in skills such as image optimization and identifying pathological conditions.

This study aims to explore whether a low-cost digital solution can provide equal educational value, offering a practical alternative to traditional simulators in resource-limited settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Piedmont
      • Turin, Italy, Piedmont, Italy, 10124
        • SimTo Advanced Medical Simulation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simulator Thoracic and Abdominal
Participants 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.
Device: Traditional Ultrasound Simulator (VausSim)
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.
Experimental: PC-based tool
Participants 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.
Device: PC-Based Ultrasound Training Tool
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Image Optimization Skills
Time Frame: Measured immediately before and after the training session.
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
Time Frame: Measured immediately before and after the training session.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction with Training
Time Frame: Measured immediately after the training session.
Participant satisfaction assessed through a Likert-scale questionnaire (1-5, where 5 = very satisfied).
Measured immediately after the training session.
Time Required for Image Acquisition
Time Frame: Measured immediately before and after the training session.
Change in the time taken to acquire specific ultrasound views in healthy volunteers and pathology recognition (measured in seconds).
Measured immediately before and after the training session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Actual)

April 25, 2024

Study Completion (Actual)

April 26, 2024

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 219864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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