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EchocardiographySLOPENCT06106178

A Novel Serious Game as an Alternative for Teaching Basic Point-of-Care Transthoracic Echocardiography Skills

A study testing Simulator for Basic Ultrasound Skills and Serious Video Game in people with Echocardiography and Education, Medical, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Echocardiography, Education, Medical
What is being tested?
Simulator for Basic Ultrasound Skills and Serious Video Game
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteAustria
Study dates
3 Oct 2023to 30 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Previous experience using an ultrasound device

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Medical University of Vienna

    Vienna, State of Vienna, 1090

Other trials in Austria

About this study

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:

Read more
  • 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.

Read the detailed description

Point-of-care ultrasound education follows non-standardized teaching and learning methods. In many cases, ultrasound is practiced directly on patients without proper training, or ultrasound simulators are used. However, these simulators are expensive to purchase and are not always readily available to students. In addition, there are a growing number of new digital tools, such as serious video games, that aim to deliver the same content in a more accessible and cost-effective manner. However, in the field of point-of-care echocardiography, there is still little scientific evidence to support their use.

This single-blind, prospective, randomized, controlled, non-inferiority trial aims to demonstrate the non-inferiority of a serious video game compared to conventional simulator-based training of basic echocardiography skills to make ultrasound training more accessible to every trainee.

Only medical students who already have the necessary anatomical knowledge but no experience with ultrasound diagnostics will be recruited to participate in this study. 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.

Being tested
Simulator for Basic Ultrasound Skills, Serious Video Game
Keywords
Echocardiography, Education, Medical, Anesthesiology, Critical Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulator for Basic Ultrasound SkillsOther

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

  • Serious Video GameOther

    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.

Study groups in NCT06106178
Study groupRoleWhat they receive
Simulator for Basic Ultrasound SkillsOtherBasic course of a traditional ultrasound simulator focusing on hand-eye coordination
Receives: Other: Simulator for Basic Ultrasound Skills
Serious Video GameOtherSerious video game "Underwater" that focuses on hand-eye coordination training using a 3D-printed ultrasound probe for maneuvering.
Receives: Other: Serious Video Game

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Two-week change from baseline to final assessment score

Secondary outcomes (25)
  1. Gender differences in modified Objective Structured Assessment of Ultrasound Skill (OSAUS) scores between the baseline and final assessment

    A two-factorial analysis of variance model (including an interaction term) will be used to determine the influence of gender in the difference of the modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. To adjust for potential imbalances between the randomized groups, the HEXACO (a measure of the six major dimensions of personality; H: Honesty-Humility; E: Emotionality; X: eXtraversion; A: Agreeableness (versus Anger); C: Conscientiousness; O: Openness to Experience) subscale of openness to experience (ranging from 1 to 5, with higher scores indicating more openness to experience) and the Technology Readiness Score (ranging from 1 to 5, with higher scores indicating more technology readiness) were included as covariates in the ANCOVA model.

    Measured: evaluation within 3 weeks after study completion

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

    A two-factorial analysis of variance model (including an interaction term) will be used to determine the potential modifying effect of gender on the training effect, which is calculated as the difference in the participant's total modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the participant's baseline assessment and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. To adjust for potential imbalances between the randomized groups, a scale for openness to experience (ranging from 1 to 5, with higher scores indicating more openness to experience) and the Technology Readiness Score (ranging from 1 to 5, with higher scores indicating more technology readiness) are included as covariates in the ANCOVA model.

    Measured: evaluation within 3 weeks after study completion

  3. Time to complete the baseline assessment

    The maximum time (minutes and seconds) to complete the baseline assessment is set to 10 minutes. Therefore, times between 0 and 10 minutes can be measured.

    Measured: up to 10 minutes

  4. Time to complete the final assessment

    The maximum time (minutes and seconds) to complete the final assessment is set to 10 minutes. Therefore, times between 0 and 10 minutes can be measured.

    Measured: up to 10 minutes

  5. Spearman correlation coefficients between the time taken and the participants learning progress

    Spearman correlation coefficients between the time taken for the final assessment and the difference in the participant's modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the participant's baseline 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.

    Measured: evaluation within 3 weeks after study completion

  6. Group difference in modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score points for each objective

    Possible scores range from 1 to 4 points per objecitve, with higher scores indicating better performance.

    Objectives are: applied knowledge of ultrasound equipment; image optimization; systematic examination; interpretation of images

    Measured: Two-week change from baseline to final assessment score

  7. Subjective confidence of participants in the use of point-of-care ultrasound (POCUS) in the context of transthoracic echocardiography after the training period

    5-point Likert Scale, with higher scores indicating greater confidence

    (1: not confident; 2: rather not confident; 3: neither confident nor not confident; 4: confident; 5: very confident)

    Measured: evaluation within 3 weeks after study completion

  8. Group difference in cognitive load while performing the final assessment as opposed to the respective cognitive load at the baseline assessment

    Global National Aeronautics and Space Administration (NASA) Task-Load-Index ranging from 0 to 100. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective score of the final assessment is calculated. Higher scores are indicating higher cognitive load.

    Measured: Two-week change from baseline to final assessment

  9. Group difference in cognitive load (per objective) while performing the final assessment as opposed to the respective cognitive load at the baseline assessment

    National Aeronautics and Space Administration (NASA) Task-Load-Index per objective, ranging from 0 to 100. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective score of the final assessment is calculated.

    Objectives are: (mental demand, physical demand, temporal demand, performance, effort, frustration). Higher scores are indicating higher mental demand/higher physical demand/ higher temporal demand/worse performance/more effort/more frustration).

    Measured: Two-week change from baseline to final assessment

  10. Subjective desire for for more new digital tools in medical education before and after the training period

    5-point Likert Scale, with higher scores indicating more desire

    (1: no desire; 2: rather not a desire; 3: neither a desire nor not a desire; 4: a desire; 5: a strong desire)

    Measured: evaluation within 3 weeks after study completion

  11. Frequency of playing video games for fun in the past 12 months before the study

    5-point Likert Scale, with higher scores indicating higher frequency

    (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)

    Measured: evaluation within 3 weeks after study completion

  12. Frequency of playing video games for educational purposes in the past 12 months before the study

    5-point Likert Scale, with higher scores indicating higher frequency

    (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)

    Measured: evaluation within 3 weeks after study completion

  13. Frequency of playing video games for fun between the ages of 6 and 18

    5-point Likert Scale, with higher scores indicating higher frequency

    (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)

    Measured: evaluation within 3 weeks after study completion

  14. Frequency of playing video games for educational purposes between the ages of 6 and 18

    5-point Likert Scale, with higher scores indicating higher frequency

    (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)

    Measured: evaluation within 3 weeks after study completion

  15. Correlation between the frequency of playing video games for fun in the past 12 months before the study and the learning progress

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the 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.

    Measured: evaluation within 3 weeks after study completion

  16. Correlation between the frequency of playing video games for educational purposes in the past 12 months before the study and the difference in the learning progress

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the 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.

    Measured: evaluation within 3 weeks after study completion

  17. Correlation between the frequency of playing video games for fun between the ages of 6 and 18 and the difference in the learning progress

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the 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.

    Measured: evaluation within 3 weeks after study completion

  18. Correlation between the frequency of playing video games for educational purposes between the ages of 6 and 18 and the difference in the learning progress

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the 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.

    Measured: evaluation within 3 weeks after study completion

  19. Correlation between the frequency of playing video games for fun in the past 12 months before the study and the desire for more digital tools in medical education before and after the training period within the study

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)

    Measured: evaluation within 3 weeks after study completion

  20. Correlation between the frequency of playing video games for educational purposes in the past 12 months before the study and the desire for more digital tools in medical education before and after the training period within the study

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)

    Measured: evaluation within 3 weeks after study completion

  21. Correlation between the frequency of playing video games for fun between the ages of 6 and 18 and the desire for more digital tools in medical education before and after the training period within the study.

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)

    Measured: evaluation within 3 weeks after study completion

  22. Correlation between the frequency of playing video games for educational purposes between the ages of 6 and 18 and the desire for more digital tools in medical education before and after the training period within the study.

    Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)

    Measured: evaluation within 3 weeks after study completion

  23. Subjective feeling of learning progress during the training period

    5-point Likert Scale measuring the subjective feeling of learning progress with the digital training tool within the randomized group

    (1: not helpful; 2: rather not helpful; 3: neither helpful nor not helpful; 4: rather helpful; very helpful)

    Measured: evaluation within 3 weeks after study completion

  24. Subjective level of frustration during the training period

    5-point Likert Scale measuring the subjective feeling of frustration while using the digital training tool within the randomized group

    (1: no frustration; 2: rather not frustrated; 3: neither frustrated nor not frustrated; 4: rather frustrated; 5: very frustrated)

    Measured: evaluation within 3 weeks after study completion

  25. Subjective level of enjoyment during the training period

    5-point Likert Scale measuring the subjective feeling of frustration while using the digital training tool within the randomized group

    (1: no enjoyment; 2: rather no enjoyment; 3: neither enjoyment nor no enjoyment; 4: rather an enjoyment; 5: strong enjoyment)

    Measured: evaluation within 3 weeks after study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start3 Oct 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106178
Sponsor's protocol ID
1289/2023
Acronym
SLOPE
Status last verified
May 2024
First submitted
3 Apr 2023
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lintschinger JM, Reischmann L, Klaus DA, Schaubmayr W, Kapral L, Dunst M, Kahlfuss F, Kaider A, Gerger G, Schaden E, Hafner C. A serious video game for teaching basic point-of-care echocardiography skills: a non-inferiority trial. BMC Med Educ. 2026 Mar 12;26(1):641. doi: 10.1186/s12909-026-08995-1.

    PubMed 41814296

Questions about this trial

What is this clinical trial studying?

A study testing Simulator for Basic Ultrasound Skills and Serious Video Game in people with Echocardiography and Education, Medical, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment (time frame: Two-week change from baseline to final assessment score). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06106178, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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