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Completed

NCT Number: NCT06106178

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

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.

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Key information

Conditions

Echocardiography Education, Medical

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous experience using an ultrasound device

Treatment and study plan

Simulator for Basic Ultrasound Skills

Other

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

Serious Video Game

Other

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: evaluation within 3 weeks after study completion

    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.

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

    Time frame: evaluation within 3 weeks after study completion

    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.

  3. Time to complete the baseline assessment

    Time frame: up to 10 minutes

    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.

  4. Time to complete the final assessment

    Time frame: up to 10 minutes

    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.

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

    Time frame: evaluation within 3 weeks after study completion

    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.

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

    Time frame: Two-week change from baseline to final assessment score

    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

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

    Time frame: evaluation within 3 weeks after study completion

    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)

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

    Time frame: Two-week change from baseline to final 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.

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

    Time frame: Two-week change from baseline to final 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).

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

    Time frame: evaluation within 3 weeks after study completion

    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)

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

    Time frame: evaluation within 3 weeks after study completion

    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)

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

    Time frame: evaluation within 3 weeks after study completion

    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)

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

    Time frame: evaluation within 3 weeks after study completion

    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)

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

    Time frame: evaluation within 3 weeks after study completion

    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)

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

    Time frame: evaluation within 3 weeks after study completion

    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.

  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

    Time frame: evaluation within 3 weeks after study completion

    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.

  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

    Time frame: evaluation within 3 weeks after study completion

    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.

  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

    Time frame: evaluation within 3 weeks after study completion

    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.

  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

    Time frame: evaluation within 3 weeks after study completion

    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)

  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

    Time frame: evaluation within 3 weeks after study completion

    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)

  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.

    Time frame: evaluation within 3 weeks after study completion

    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)

  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.

    Time frame: evaluation within 3 weeks after study completion

    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)

  23. Subjective feeling of learning progress during the training period

    Time frame: evaluation within 3 weeks after study completion

    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)

  24. Subjective level of frustration during the training period

    Time frame: evaluation within 3 weeks after study completion

    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)

  25. Subjective level of enjoyment during the training period

    Time frame: evaluation within 3 weeks after study completion

    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)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: SLOPE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2023
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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