NCT06516250

Brief 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. 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. .

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Jul 2024

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2024Sep 2027

First Submitted

Initial submission to the registry

July 12, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

3.2 years

First QC Date

July 12, 2024

Last Update Submit

July 18, 2024

Conditions

Keywords

Serious gameSimulationGamificationKnowledgeLearning methodologiesUrgencyEmergency

Outcome Measures

Primary Outcomes (4)

  • 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.

    one year

  • 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.

    one year

  • 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.

    one year

  • 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.

    one year

Study Arms (2)

Group with serious game

EXPERIMENTAL

The 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.

Other: Virtual serious game GEMAS

Group traditional methods of learning

NO INTERVENTION

They will not be able to use the application, its teaching method will be based on theoretical master classes.

Interventions

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.

Group with serious game

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BehaviorEmergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Munir Mohamed Mimun, Mr

CONTACT

Esther Jovell Fernandez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Once the data is obtained, it will be sent to the results analysts who will also not know the authorship of the data obtained.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 23, 2024

Study Start

July 22, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

July 23, 2024

Record last verified: 2024-07