Clinical trial NCT06775899: Equivalence Study Comparing a Cost-Effective PC-Based Ultrasound Training Tool to Traditional Simulators in Third-Year Medical Students
Official title: Evaluating the Efficacy of a Cost-Effective PC-Based Tool as a Non-Inferior Alternative to Traditional Ultrasound Simulators in Medical Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Medical Training
Simulation Based Learning
Medical Student
Keywords: Medical Education
Ultrasound Simulation
PC-Based Training Tool
Thoracic Ultrasound
Abdominal Ultrasound
Cost-effective Simulator
Clinical Skills Development
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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?

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Image Optimization Skills
timeFrame: Measured immediately before and after the training session.
measure: Pathology Recognition Accuracy
timeFrame: Measured immediately before and after the training session.
Secondary outcomes:
measure: Participant Satisfaction with Training
timeFrame: Measured immediately after the training session.
measure: Time Required for Image Acquisition
timeFrame: Measured immediately before and after the training session.
Other outcomes:
Locations:
city: Turin, Italy
country: Italy
facility: SimTo Advanced Medical Simulation Centre
state: Piedmont
Study officials:
References:
citation: 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.
citation: Weimer 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.
citation: Pezel 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.
citation: Damewood 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.