NCT06106178

Brief Summary

The goal of this clinical trial is to compare different digital learning methods for teaching basic skills in point-of-care transthoracic echocardiography to medical students. The main question it aims to answer is: • Is a novel digital learning tool, such as a serious video game, non-inferior to traditional ultrasound simulator teaching methods in the context of basic point-of-care transthoracic echocardiography skills training? Participants will train basic point-of-care ultrasound skills using either a traditional basic ultrasound simulator course or the serious video game "Underwater". Both methods focus on training hand-eye coordination, which is particularly important in transthoracic echocardiography. To compare the performance of the participants, a baseline assessment will be performed before and a final assessment after the two-week training period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

February 11, 2025

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

April 3, 2023

Last Update Submit

February 7, 2025

Conditions

Keywords

EchocardiographyEducation, MedicalAnesthesiologyCritical Care

Outcome Measures

Primary Outcomes (1)

  • Difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment

    The primary outcome measure is the difference in the participant's modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the participants' baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective final assessment score is calculated.

    Two-week change from baseline to final assessment score

Secondary Outcomes (25)

  • Gender differences in modified Objective Structured Assessment of Ultrasound Skill (OSAUS) scores between the baseline and final assessment

    evaluation within 3 weeks after study completion

  • Group effects on gender differences in modified Objective Structured Assessment of Ultrasound Skill (OSAUS) scores

    evaluation within 3 weeks after study completion

  • Time to complete the baseline assessment

    up to 10 minutes

  • Time to complete the final assessment

    up to 10 minutes

  • Spearman correlation coefficients between the time taken and the participants learning progress

    evaluation within 3 weeks after study completion

  • +20 more secondary outcomes

Study Arms (2)

Simulator for Basic Ultrasound Skills

OTHER

Basic course of a traditional ultrasound simulator focusing on hand-eye coordination

Other: Simulator for Basic Ultrasound Skills

Serious Video Game

OTHER

Serious video game "Underwater" that focuses on hand-eye coordination training using a 3D-printed ultrasound probe for maneuvering.

Other: Serious Video Game

Interventions

Basic course of a traditional ultrasound simulator focusing on hand-eye coordination

Simulator for Basic Ultrasound Skills

The serious video game "Underwater" uses a 3D-printed ultrasound probe for maneuvering. During gameplay, coins must be collected in an underwater world using the aforementioned simulated ultrasound probe. The main focus of this game is to improve hand-eye coordination while using an ultrasound probe.

Serious Video Game

Eligibility Criteria

Age18 Years - 110 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants will be asked about their gender identity and will be randomized equally per gender to the control or intervention group.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student at the Medical University of Vienna (Medicine Degree Program)
  • ≥18 years
  • Basic knowledge of anatomy (completed Block 2 of the MUV curriculum)

You may not qualify if:

  • Previous experience using an ultrasound device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The POCUS examinations are videotaped without the possibility of identifying the participant. A camera visually records the movements of the ultrasound probe and the participant's hand, while a pen is used to mark the appropriate structures on the frozen ultrasound images. The audio recordings of these videos are transcribed and presented to the evaluators in written form only. After all participants have completed the baseline assessment, these two videos from each participant will be edited together and can be presented to the experts for evaluation as a compact video along with the transcribed audio recordings. In addition, the videos and audio transcripts presented to the experts will be labeled with randomly generated numbers for scoring.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will attend a 90-minute workshop to learn the basics of point-of-care echocardiography. They will then be required to perform standardized transthoracic echocardiography before and after a two-week training period, which will be scored by blinded experts. During the training phase, one group will practice the hand-eye coordination required for echocardiography using an ultrasound simulator, while the second group will practice the same content using a serious video game. In addition, questionnaires will be used to collect additional data from the participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2023

First Posted

October 30, 2023

Study Start

October 3, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

February 11, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations