ArrythmiaNCT06266845
Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients
A study testing In-person Escape Room and Virtual Escape-Room in people with Arrythmia and Health Education, run by University of Brasilia at 1 site in Brazil.
Trial summary
Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrythmia, Health Education, Escape-Room
- What is being tested?
- In-person Escape Room and Virtual Escape-Room
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Mar 2024to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students enrolled in the undergraduate nursing program who have successfully completed the course related to adult and elderly health.
Who cannot join
- Healthcare professionals, including those participants who, at any point during the research stages, choose to withdraw or who have not completed/participated in one of the study phases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Alberto Augusto Martins Paiva
Brasília, Federal District, 71938360
Alberto Augusto M Paiva, Graduate, +5561983470397, albertopaiva19@hotmail.com
About this study
Official title: Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients: an Experiment With Nursing Undergraduates
Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. However, few studies have explored the use of both in-person and virtual escape-room as an educational methodology in nursing. Objective: To assess the effectiveness of the gamification strategy through the in-person escape-room model compared to the virtual model in enhancing cognitive and affective competencies for recognizing cardiac arrhythmias in critical care patients within the nursing field. Method: A randomized clinical trial to be conducted with nursing students from higher education institutions in the Federal District, Brazil. Students will undergo a theoretical class on cardiac arrhythmias in critical patients and will then be randomized to experience either the in-person or virtual escape-room scenario. Knowledge tests, the Depression, Anxiety, and Stress Scale, Satisfaction and Self-confidence Scale in nursing management learning, and perceived gains will be administered pre and post-intervention. Results with p≤0.05 will be considered significant. Expected Results: It is anticipated that this study will contribute to the enhancement and broadening of cognitive and affective competencies in nursing students, improving the quality of care through an active educational strategy like the escape-room, and consequently reducing costs for the Unified Health System by minimizing errors in recognizing clinical changes in critical patients. Additionally, the study aims to address gaps in understanding the use of educational escape-rooms in the field of nursing.
- Conditions
- Arrythmia, Health Education, Escape-Room
- Being tested
- In-person Escape Room, Virtual Escape-Room
- Medical subject headings
- Arrhythmias, Cardiac, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person Escape RoomBehavioural
The in-person escape room will be conducted in the nursing laboratory of a Higher Education Institution (HEI), equipped with a high-fidelity mannequin to simulate a critical patient and create a realistic environment. Participants will be divided into groups, with one group entering at a time as requested. During the in-person escape room, participants will interact with the patient mannequin, hospital equipment and devices, as well as with objects and clues in the environment. The game duration will be 30 minutes to ensure equal conditions among participants and prevent time distortions. Interactions and participants' performance will be recorded by the facilitator, guiding the feedback.
Virtual Escape-RoomBehavioural
The virtual escape room will be conducted in a classroom of an HEI, utilizing an online platform that allows the virtual reproduction of the game. Each group will have access to a tablet or computer to participate in the game provided by the researcher. During the game, participants will interact with the platform interface and solve challenges to escape the virtual room within 30 minutes. Thus, each group will have a maximum of 30 minutes to complete the escape room, ensuring equal conditions among participants. Records of interactions and participant performance will be logged for later analysis and feedback.
| Study group | Role | What they receive |
|---|---|---|
| Knowledge Test | Other | Not described Receives: Behavioral: In-person Escape Room; Behavioral: Virtual Escape-Room |
| Knowledge Test Satisfaction and Self-Confidence Scale | Other | Not described Receives: Behavioral: In-person Escape Room; Behavioral: Virtual Escape-Room |
| Perceived Gains Scale and DASS-21 (Depression, Anxiety, and Stress Scale-21) | Other | Not described Receives: Behavioral: In-person Escape Room; Behavioral: Virtual Escape-Room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feelings of stress and anxiety among nursing students after experiencing the in-person and virtual escape-room combined with an interactive lecture
The Depression, Anxiety, and Stress Scale (DASS-21) will be necessary to assess the impact of the intervention on the stress experienced by students during the process. The scale consists of 21 items, with seven items in each of the three scales (depression, anxiety, and stress). The minimum and maximum scores for each subscale are determined by the sum of the values assigned to the corresponding items. Generally, for each of the three subscales, the minimum possible score is 0, indicating the absence of symptoms, while the maximum score varies depending on the intensity of the responses provided by participants to specific items. For example, on a scale of 0 to 21 for each subscale, a higher score suggests higher levels of depression, anxiety, or stress.
Measured: 3 months
Perceived Gains Scale
Another instrument that will be used in the study is the Perceived Gains Scale, which consists of 25 items with 5 response options: Improved immensely; improved considerably; improved slightly; stayed the same; got worse. In this scale, the different variables identify students' perceptions of the gains achieved through their experience with high-fidelity patient mannequins at the cognitive level.
Measured: 3 months
Student Satisfaction and Self-Confidence in Learning
The "Student Satisfaction and Self-Confidence in Learning" Scale was developed to measure individuals' satisfaction and self-confidence acquired through high-fidelity simulations. This instrument has been validated in Brazil and will be used in the present study following the intervention. The scale consists of 26 items, organized into five factors: the usefulness and effectiveness of teaching methods, the provision of didactic materials and activities, the quality of teaching provided by the facilitator, self-confidence in learning, and student responsibility for their own learning. Participants indicate their level of agreement with each item on a five-point scale, ranging from "strongly disagree" to "strongly agree." The closer to 5, the higher the level of satisfaction with learning and self-confidence.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start4 Mar 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Cristina da Silva Magro, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266845
- Sponsor's protocol ID
- 76082423.1.0000.8093
- Status last verified
- Jul 2024
- First submitted
- 27 Jan 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients: an Experiment With Nursing Undergraduates
- ClinicalTrials.gov ID
- NCT06266845
- Acronym / sponsor ID
- 76082423.1.0000.8093
- Conditions
- Arrythmia, Health Education, Escape-Room
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. However, few studies have explored the use of both in-person and virtual escape-room as an educational methodology in nursing. Objective: To assess the effectiveness of the gamification strategy through the in-person escape-room model compared to the virtual model in enhancing cognitive and affective competencies for recognizing cardiac arrhythmias in critical care patients within the nursing field. Method: A randomized clinical trial to be conducted with nursing students from higher education institutions in the Federal District, Brazil. Students will undergo a theoretical class on cardiac arrhythmias in critical patients and will then be randomized to experience either the in-person or virtual escape-room scenario. Knowledge tests, the Depression, Anxiety, and Stress Scale, Satisfaction and Self-confidence Scale in nursing management learning, and perceived gains will be administered pre and post-intervention. Results with p≤0.05 will be considered significant. Expected Results: It is anticipated that this study will contribute to the enhancement and broadening of cognitive and affective competencies in nursing students, improving the quality of care through an active educational strategy like the escape-room, and consequently reducing costs for the Unified Health System by minimizing errors in recognizing clinical changes in critical patients. Additionally, the study aims to address gaps in understanding the use of educational escape-rooms in the field of nursing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knowledge Test | Other | Behavioral: In-person Escape Room, Behavioral: Virtual Escape-Room |
| Knowledge Test Satisfaction and Self-Confidence Scale | Other | Behavioral: In-person Escape Room, Behavioral: Virtual Escape-Room |
| Perceived Gains Scale and DASS-21 (Depression, Anxiety, and Stress Scale-21) | Other | Behavioral: In-person Escape Room, Behavioral: Virtual Escape-Room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students enrolled in the undergraduate nursing program who have successfully completed the course related to adult and elderly health.
Key exclusion criteria (1 listed)
- Healthcare professionals, including those participants who, at any point during the research stages, choose to withdraw or who have not completed/participated in one of the study phases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person Escape RoomThe in-person escape room will be conducted in the nursing laboratory of a Higher Education Institution (HEI), equipped with a high-fidelity mannequin to simulate a critical patient and create a realistic environment. Participants will be divided into groups, with one group entering at a time as requested. During the in-person escape room, participants will interact with the patient mannequin, hospital equipment and devices, as well as with objects and clues in the environment. The game duration will be 30 minutes to ensure equal conditions among participants and prevent time distortions. Interactions and participants' performance will be recorded by the facilitator, guiding the feedback. | Behavioural | Knowledge Test, Knowledge Test Satisfaction and Self-Confidence Scale, Perceived Gains Scale and DASS-21 (Depression, Anxiety, and Stress Scale-21) |
| Virtual Escape-RoomThe virtual escape room will be conducted in a classroom of an HEI, utilizing an online platform that allows the virtual reproduction of the game. Each group will have access to a tablet or computer to participate in the game provided by the researcher. During the game, participants will interact with the platform interface and solve challenges to escape the virtual room within 30 minutes. Thus, each group will have a maximum of 30 minutes to complete the escape room, ensuring equal conditions among participants. Records of interactions and participant performance will be logged for later analysis and feedback. | Behavioural | Knowledge Test, Knowledge Test Satisfaction and Self-Confidence Scale, Perceived Gains Scale and DASS-21 (Depression, Anxiety, and Stress Scale-21) |
Primary outcome
Evaluate the feelings of stress and anxiety among nursing students after experiencing the in-person and virtual escape-room combined with an interactive lecture
Time frame: 3 months
The Depression, Anxiety, and Stress Scale (DASS-21) will be necessary to assess the impact of the intervention on the stress experienced by students during the process. The scale consists of 21 items, with seven items in each of the three scales (depression, anxiety, and stress). The minimum and maximum scores for each subscale are determined by the sum of the values assigned to the corresponding items. Generally, for each of the three subscales, the minimum possible score is 0, indicating the absence of symptoms, while the maximum score varies depending on the intensity of the responses provided by participants to specific items. For example, on a scale of 0 to 21 for each subscale, a higher score suggests higher levels of depression, anxiety, or stress.
Perceived Gains Scale
Time frame: 3 months
Another instrument that will be used in the study is the Perceived Gains Scale, which consists of 25 items with 5 response options: Improved immensely; improved considerably; improved slightly; stayed the same; got worse. In this scale, the different variables identify students' perceptions of the gains achieved through their experience with high-fidelity patient mannequins at the cognitive level.
Student Satisfaction and Self-Confidence in Learning
Time frame: 3 months
The "Student Satisfaction and Self-Confidence in Learning" Scale was developed to measure individuals' satisfaction and self-confidence acquired through high-fidelity simulations. This instrument has been validated in Brazil and will be used in the present study following the intervention. The scale consists of 26 items, organized into five factors: the usefulness and effectiveness of teaching methods, the provision of didactic materials and activities, the quality of teaching provided by the facilitator, self-confidence in learning, and student responsibility for their own learning. Participants indicate their level of agreement with each item on a five-point scale, ranging from "strongly disagree" to "strongly agree." The closer to 5, the higher the level of satisfaction with learning and self-confidence.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person Escape Room and Virtual Escape-Room in people with Arrythmia and Health Education, run by University of Brasilia at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Augusto M Martins Paiva (+5561983470397, albertopaiva19@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feelings of stress and anxiety among nursing students after experiencing the in-person and virtual escape-room combined with an interactive lecture (time frame: 3 months). The study lists 3 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 10 Jul 2024.