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Knowledge, Attitudes, PracticeNCT06516250

GEMAS Proyect. Gamification in Nursing and Medicine for Simulation Learning.

A study testing Virtual serious game GEMAS in people with Knowledge, Attitudes, Practice, run by Consorci Sanitari de Terrassa.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The GEMAS project is based on the creation of a virtual serious game in which, by carrying out clinical cases that simulate real environments and episodes of a hospital emergency service, the aim is to improve and reinforce the knowledge of the participants with the use of a new learning methodology. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Knowledge, Attitudes, Practice
What is being tested?
Virtual serious game GEMAS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
No sites listed yet
Study dates
22 Jul 2024to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Medical and Nursing Students: Students enrolled in undergraduate programs in medicine (5th and 6th year) or nursing (3rd and 4th year). They may be from various faculties.
  • MIR and EIR Residents: Residents in training in medicine or nursing, from various years of residency and specialties.
  • Geographic Diversity: Participants from different geographic regions or urban areas.
  • Cultural and Linguistic Diversity: Participants from diverse cultures and ethnic groups.
  • Willingness to Participate: Commitment of participants to actively participate in the study.

Who cannot join

  • Previous Experience in Similar Cases: Participants who have had previous experience in similar clinical cases or who have received specific training related to the content of the game.
  • Severe Mental or Physical Health Issues: Participants who have severe mental or physical health issues that may affect their ability to participate in the study or adequately understand the content of the game.
  • Conditions Affecting Active Participation: Participants who have conditions that limit their ability to actively participate in the study (states of intoxication, etc.).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Munir Mohamed Mimun, Mr contact

+34 655974937

munirholmes@hotmail.com

Esther Jovell Fernandez, PhD contact

+34 937003657

ejovell@cst.cat

About this study

The GEMAS project is based on the creation of a virtual serious game in which, by carrying out clinical cases that simulate real environments and episodes of a hospital emergency service, the aim is to improve and reinforce the knowledge of the participants with the use of a new learning methodology.

The mapping and creation of several scenarios within the program is carried out, the creation of different characters, both main and secondary, patients and hospital environment, each of them with their graphic representation, characteristics and individual personality.

After obtaining the program, which can be used on both computer and mobile platforms, the virtual serious-game will be evaluated with the levels of the Kirkpatrick model to be used as a new learning tool. The degree of satisfaction and usability will be evaluated at the first level, the degree of knowledge acquisition by the participant himself and in comparison with traditional methodologies at the second level, the changes in behavior and transfer of the knowledge learned to the professional field in the third level, and the possibility of knowing the effectiveness of the application for the system will be evaluated. The virtual serious game will allow you to select between the nursing or medicine modality, allowing a greater number of cases to be developed and at the same time, for both stories to be related, so that interdisciplinarity remains intrinsically rooted in the game. The creation of this application will create dynamic learning that will allow greater user satisfaction while learning and a greater degree of knowledge acquisition with respect to traditional methods, ultimately producing changes in work behavior that are favorable for the performance of their profession. .

Read the detailed description

Specific Objective 1

The design of the application will be carried out using the RPG Maker MV program, an online purchase programming tool that grants the buyer intellectual property and commercialization rights. After acquiring the program, a hospital environment will be created, in this case, an Emergency Medical System, creating different characters including patients, family members, doctors, nurses, and administrative staff. The stories will be divided into two for gameplay, depending on whether the player chooses to be a nurse or a doctor. Consequently, the stories are different, and the characters represent a series of cases and varying complexity, adapted to the decision of which profession to pursue in the game. The characters will be created using the Midjourney™ web application as sketches, which will then undergo multiple image changes with GIMP 2.10, Paint, and PowerPoint until the desired images of the different characters are achieved.

In the content of the virtual serious game, two stories will be created with the intention of learning about various common deficits or errors made by novice doctors and nurses.

To design the content, an expert group will be formed, requesting the participation of professionals with extensive experience in the field of medical emergencies and nursing with an interdisciplinary vision, who wish to participate in the creation of case content.

Specific Objective 2

To evaluate the degree of satisfaction and usability of the virtual serious game, surveys or questionnaires will be used. The degree of usability will be measured using the SUS (System Usability Scale), which aims to assess navigation, interface design, and accessibility. This scale, created in 1986 by John Brooke, is widely validated for measuring the usability of systems and products, including software, hardware, mobile applications, and other interactive systems. It is based on responses to 10 items rated on a 4-point Likert scale (from strongly disagree to strongly agree).

Direct observation of the game functioning will also provide feedback on programming, image, and development errors in the application, allowing us to make the necessary modifications.

To assess the degree of satisfaction, the 9-question Kirkpatrick model questionnaire will be used, presenting questions with Likert scale ratings and open-ended questions. Additional questions from the Questionnaire for User Interaction Satisfaction (QUIS), a widely validated scale used to evaluate user satisfaction with interaction systems, including software and educational applications, will be added. This will complement the Kirkpatrick scale due to the lack of questions evaluating interactions with software and computer systems. The QUIS was developed at the Human-Computer Interaction Lab at the University of Maryland and has been validated through multiple academic studies and practical applications. This scale traditionally scores from 1-very dissatisfied to 9-very satisfied, evaluating various aspects of user satisfaction. The QUIS questions that best address the information we want to obtain from the project will be selected and added to the Kirkpatrick level 1 model questions.

Specific Objective 3

To evaluate the degree of clinical knowledge acquired, a knowledge questionnaire will be designed in conjunction with a consensus of experts using the Delphi method. For the creation of the questionnaire, a literature review will be conducted to establish that there is currently no agreement among researchers on using a scale that measures the knowledge we want to evaluate and reinforce in the students. Therefore, the question "How can I evaluate the knowledge of virtual serious game participants before and after its use to know the degree of learning acquired?" will be posed.

Once the absence of such a scale is identified, a group will be constituted to coordinate the process, comprising the thesis directors and the doctoral candidate. The functions will include creating a group of experts in emergency medicine and nursing to contribute their knowledge and involvement in improving knowledge for our project. A study and approval of the expert list will be conducted, the questionnaire will be developed, expert participation will be encouraged, responses from the rounds will be analyzed, subsequent questionnaires or questions will be prepared and feedback provided, and the process will be supervised, proposing and taking corrective measures if necessary, and ultimately interpreting the results. Feedback will serve as the link between the experts and the coordinators, allowing information flow and improving the final product quality.

Specific Objective 4

During the beginning of residency, both nurses and doctors are instructed in preparatory classes before starting their shifts and rotations in the Emergency Department. Two groups will be selected: an intervention group that will use the virtual serious game after the lectures given at the center, and a control group that will follow the traditional lecture method for knowledge acquisition.

The intervention group will be allowed to enjoy the virtual serious game for the hours needed to advance through the difficulty levels until completing 100% of the virtual serious game. Subsequently, as indicated in objective 3, a post-test will be administered, collecting responses on the knowledge that the virtual serious game and the emergency lectures are expected to cover.

In the control group, after attending lectures that cover the topics addressed by the virtual serious game, the same post-test will be administered. This way, we can determine whether the use of the virtual serious game is favorable for clinical knowledge acquisition by producing statistically significant results compared to the control group.

Participant selection for both groups will follow a series of steps:

Participant acceptance according to inclusion and exclusion criteria and their willingness to participate in the study.

Sample stratification, separating doctors and nurses, and those who have previously worked or are in their second residency from the more novice participants.

Randomization of participants into the control and intervention groups using randomization software or a traditional random number table method.

Assignment by a third person, avoiding, as much as possible, the ability of the person assigning participants to identify them. This would be achieved by using identification codes instead of participant names.

Specific Objective 5

To evaluate the application of the virtual serious game for clinical case simulation as a preparation tool for the Objective Structured Clinical Examination (OSCE), a methodology similar to that described in objective 4 will be used. However, in this case, samples will be obtained from medical and nursing students, who will consent to participate in the study and to share their OSCE scores for evaluation.

The selection of intervention and control groups will be made by selecting users who want to participate in the study before the OSCE. Those students who meet the inclusion and exclusion criteria will be selected through stratified (by faculty and geographic location) and randomized allocation to the intervention and control groups. The selection will be blinded, resulting in two groups:

Intervention group: Will have access to the application on their mobile phone or PC at the teaching center, being able to complete the game before the OSCE.

Control group: Will take the OSCE using traditional learning and knowledge acquisition techniques currently employed at the center.

Once both groups are obtained and the intervention with the virtual serious game tool is completed, OSCE results will be collected to evaluate whether there are statistically significant differences between the intervention and control groups.

Specific Objective 6

Evaluate behavioral changes in professionals using the application. To do this, the 6-question Kirkpatrick model questionnaire will be used to determine if there are changes in participants' habits and if there are limitations to its use or development.

Being tested
Virtual serious game GEMAS
Keywords
Serious game, Simulation, Gamification, Knowledge, Learning methodologies, Urgency, Emergency
Medical subject headings
Behavior, Emergencies

What participants receive

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

  • Virtual serious game GEMASOther

    Implement and evaluate a virtual serious game designed to improve the learning and retention of clinical knowledge in medicine and nursing students and residents through the simulation of clinical cases in a hospital emergency environment.

Study groups in NCT06516250
Study groupRoleWhat they receive
Group with serious gameExperimentalThe participants will recived the same theoretical master classes and they will use the serious game for a series of hours and will be able to learn using this new teaching methodology, whether on a computer or mobile.
Receives: Other: Virtual serious game GEMAS
Group traditional methods of learningNo interventionThey will not be able to use the application, its teaching method will be based on theoretical master classes.

What is being measured

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

  1. Satisfaction of the virtual serious game

    Measured using the 9-question Kirkpatrick model survey, supplemented with questions from the QUIS (Questionnaire for User Interaction Satisfaction) survey.

    This scale traditionally makes scores from 1- very dissatisfied to 9- very satisfied, evaluating various aspects of user satisfaction such as:

    • Global experience: user's general perception of the system.
    • Screens: design and layout of the screens.
    • Terminology and information system: clarity and appropriateness of the language used.
    • Learning: ease with which users can learn to use the system.
    • System responsiveness: speed and efficiency of system responses.
    • Usability impression: perceived ease of use.

    Measured: one year

  2. Usability of the virtual serious game

    Usability will be measured with the System Usability Scale (SUS). It is based on providing answers to 10 items that users rate using a 4-point Likert scale (not at all agree 1, to completely agree 4). The items that are evaluated in this scale are:

    Frequency of Use, Complexity. Ease of Use, Need for Technical Support, Integration of Functionalities, Consistency, Ease of Learning, Cumbersomeness, Confidence and Learning Load.

    Measured: one year

  3. Clinical knowledge

    Measured using a questionnaire validated by a consensus of experts conducted with the Delphi method, with post-test questions added for calibration of the Kirkpatrick method.

    The answer could be correct, partially correct or wrong. The calibration answer are open answer that would give information to the creators to know the subjetive opinion of the participants.

    Measured: one year

  4. Transfer and behavior after using the serious game modules

    Evaluated using the 6-question Kirkpatrick model survey. The answers would be open answers to know the opinion of the participants and what kind of problems or facilities they have found during the develop of their activities and use of the knowledge and tools achieved during the programme.

    Measured: one year

Timeline

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

  1. First posted23 Jul 2024
  2. Study start22 Jul 2024 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

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
Students enrolled in 5th and 6th year medicine or 3rd and 4th year nursing degree programs. They can be from various faculties. Residents in training in medicine or nursing, from various years of residency and specialties.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
121 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516250
Sponsor's protocol ID
GEMASMMM2024
Status last verified
Jul 2024
First submitted
12 Jul 2024
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Virtual serious game GEMAS in people with Knowledge, Attitudes, Practice, run by Consorci Sanitari de Terrassa.

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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Munir Mohamed Mimun, Mr (+34 655974937, munirholmes@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction of the virtual serious game (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Jul 2024.

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