NCT07404501

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 4, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

BurnsHealth EducationAccident PreventionFirst AidEducational Games

Outcome Measures

Primary Outcomes (1)

  • Change in Knowledge Scores on Burn Prevention and First Aid After the Educational Interventions

    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.

    From baseline to immediately post-intervention

Secondary Outcomes (1)

  • Knowledge Retention Scores After the Educational Interventions

    From baseline to 2 weeks post-intervention

Other Outcomes (1)

  • Participant Satisfaction With the Educational Interventions

    Immediately after the intervention

Study Arms (2)

Serious Digital Game

EXPERIMENTAL

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.

Behavioral: Serious Digital Game for Burn Prevention and First Aid

Face-to-Face Educational Lecture

ACTIVE COMPARATOR

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.

Behavioral: Face-to-Face Educational Lecture on Burn Prevention and First Aid

Interventions

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.

Face-to-Face Educational Lecture

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.

Serious Digital Game

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, Universidade de São Paulo, SP, Brazil

São Paulo, São Paulo, 01246 903, Brazil

Location

MeSH Terms

Conditions

BurnsHealth Education

Interventions

First Aid

Condition Hierarchy (Ancestors)

Wounds and InjuriesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Emergency TreatmentTherapeutics

Study Officials

  • Cristina Pires Camargo, Md, PhD

    Laboratory of Plastic Surgery and Regenerative Medicine, School of Medicine, Universidade de São Paulo, SP, Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Pires Camargo, Md, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

February 1, 2026

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study involves educational interventions with students and includes potentially sensitive personal and sociodemographic information. Data sharing was not included in the ethics committee approval, and participant consent did not authorize public sharing of individual-level data. Only aggregated and anonymized results will be reported.

Locations