- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404501
Gamified Approach To Burn Education
A Gamified Approach To Burn Education And Prevention Among Youth: The Randomized Controlled Study "Burn Game"
The goal of this clinical trial is to evaluate whether different educational strategies can improve knowledge acquisition regarding burn prevention and first aid among students enrolled in a community-based preparatory course. The main questions it aims to answer are:
Does participation in a serious digital game improve knowledge about burn prevention and first aid compared with a traditional lecture? Researchers will compare a serious digital game with a face-to-face educational lecture to determine differences in knowledge acquisition and participant satisfaction between the two educational approaches.
Participants will:
Receive a brief (5 minutes) standardized introductory explanation about basic concepts of burns; Be randomized to participate in either a serious digital game or a face-to-face educational lecture; Complete knowledge assessment questionnaires prior to and after the intervention; Complete a satisfaction questionnaire; Attend a follow-up assessment two weeks after the intervention.
Study Overview
Status
Conditions
Detailed Description
This study is a randomized, single-blind, behavioral and educational intervention with two parallel arms designed to evaluate different educational strategies for burn prevention and first aid.
All participants will initially receive a brief (5 minutes) standardized introductory session covering basic concepts related to burns, including definition, common causes, prevention strategies, and first-aid measures. This introductory explanation is intended to ensure that all participants have a minimum and uniform baseline understanding of the topic prior to the intervention.
After this initial session, participants will be randomly allocated to one of two intervention groups.
Participants allocated to the serious digital game group will receive a 5-minute familiarization period with the digital platform, followed by 25 minutes of gameplay. The serious game presents educational content and questions related to burn prevention and first aid through virtual avatars, requiring participants to consult in-game educational materials before answering questions. Performance is recorded automatically by the game system.
Participants allocated to the face-to-face educational lecture group will attend an in-person lecture lasting approximately 30 minutes. The lecture will address types of burns, etiology, prevention measures, and basic first-aid management in primary health care.
Knowledge acquisition will be assessed using structured multiple-choice questionnaires administered prior to and after the intervention. Participant satisfaction will also be evaluated using a Likert-scale questionnaire. A follow-up assessment will be conducted two weeks after the intervention to evaluate knowledge retention.
Outcome assessment will be performed by an evaluator blinded to group allocation. Sociodemographic variables, including age, sex, and socioeconomic status, will be collected.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo
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São Paulo, São Paulo, Brazil, 01246 903
- School of Medicine, Universidade de São Paulo, SP, Brazil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students regularly enrolled in the MedEnsina preparatory course
- Ability to understand the instructions and the content of the proposed educational activities
- Availability to participate in the intervention on the first day of the study and to attend the two-week follow-up
- Signed informed consent form and, when applicable, assent form
Exclusion Criteria:
- Failure to attend the intervention on the first day of the study
- Failure to attend the follow-up assessment two weeks after the intervention
- Incomplete completion of the pre- or post-intervention questionnaires
- Withdrawal of consent at any stage of the study
- Any condition that, in the investigators' judgment, may impair adequate participation or understanding of the educational activities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Serious Digital Game
Participants in this arm will receive a brief standardized introductory session covering basic concepts of burns, including causes, prevention, and first aid.
After this introduction, participants will engage in a serious digital game for 25 minutes following a 5-minute familiarization period with the platform, totaling 30 minutes.
The game presents educational content and questions related to burn prevention and first aid through virtual avatars.
Participants are required to consult in-game educational materials before answering questions.
Performance is assessed based on accuracy and response time, generating an automated final score.
Participants will complete a post-intervention knowledge assessment questionnaire and a satisfaction questionnaire at the end of the intervention, as well as a follow-up assessment two weeks later.
|
The intervention consists of a serious digital game designed to provide education on burn prevention and first aid.
The game delivers educational content through an interactive virtual environment in which participants engage with avatars that present questions and learning challenges related to burns.
Participants are required to consult in-game educational materials before responding to each question.
Performance metrics, including response accuracy and time to answer, are recorded automatically by the system to generate an overall score - which is not an endpoint of this study, since the control group does not have access to the game.
The intervention is intended to promote active learning and knowledge acquisition through interactive and gamified educational strategies.
|
|
Active Comparator: Face-to-Face Educational Lecture
Participants in this arm will first receive a brief standardized introductory session covering basic concepts of burns, including causes, prevention, and first aid.
After this introduction, participants will attend a face-to-face educational lecture lasting 30 minutes, addressing types of burns, etiology, prevention strategies, and basic first-aid measures.
Participants will complete pre- and post-intervention knowledge assessment questionnaires, as well as a follow-up assessment two weeks after the intervention.
|
The intervention consists of an in-person 30-minute educational lecture focused on burn prevention and first aid.
The lecture is designed to deliver structured educational content in a didactic format, covering key topics related to burns, including common causes, prevention strategies, and basic first-aid measures.
The session is conducted by a trained instructor and aims to provide participants with foundational knowledge through direct instruction, without the use of interactive gaming components.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knowledge Scores on Burn Prevention and First Aid After the Educational Interventions
Time Frame: From baseline to immediately post-intervention
|
The primary outcome is knowledge acquisition related to burn prevention and first aid.
Knowledge will be assessed using a structured multiple-choice questionnaire administered immediately before and immediately after the educational intervention.
The questionnaire will be delivered through the Google Forms platform and consists of 20 multiple-choice questions, each with four response options, covering basic concepts of burns, prevention strategies, and first-aid measures.
Each correct answer contributes to the total knowledge score, with higher scores indicating greater knowledge.
The primary outcome will be expressed as the change in knowledge score from baseline to immediately after the intervention and will be compared between the two educational groups.
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From baseline to immediately post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge Retention Scores After the Educational Interventions
Time Frame: From baseline to 2 weeks post-intervention
|
Knowledge retention related to burn prevention and first aid will be assessed using the same structured multiple-choice questionnaire applied during the initial evaluation.
The questionnaire will be administered online using Google Forms and consists of 20 multiple-choice questions, each with four response options, covering basic concepts of burns, prevention strategies, and first-aid measures.
It will be administered again approximately two weeks after the educational intervention to evaluate the extent to which the information learned was retained over time.
The total score obtained at the follow-up assessment will be compared with baseline and immediate post-intervention scores.
Higher scores indicate greater retention of knowledge.
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From baseline to 2 weeks post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Satisfaction With the Educational Interventions
Time Frame: Immediately after the intervention
|
Participant satisfaction with the educational intervention will be assessed immediately after completion of the intervention.
Satisfaction will be evaluated for all participants using a structured questionnaire based on a 5-point Likert scale, validated for Brazilian Portuguese, to assess participants' perceptions of the educational experience, including clarity of content, engagement, usability, and overall satisfaction.
Additionally, participants in the digital game intervention group will complete the User Experience Questionnaire (USERQ), a validated instrument that uses a 5-point scale to assess user experience with digital technologies, in order to evaluate interaction with the digital game platform.
Higher scores indicate greater participant satisfaction with the educational intervention.
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Immediately after the intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Cristina Pires Camargo, Md, PhD, Laboratory of Plastic Surgery and Regenerative Medicine, School of Medicine, Universidade de São Paulo, SP, Brazil
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90231725.9.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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