- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07922057
Mobile Game-Based Versus Classic First Aid Education in Adolescents: Randomized Controlled Trial (CanKurtaranRCT)
Comparison of the Effectiveness of First Aid Education Delivered Through a Mobile Serious Game and the Classic Education Method in Adolescents Aged 14-17 Years: A Three-Arm, Stratified Randomized Controlled Trial
The goal of this three-arm, stratified randomized controlled trial is to learn whether a mobile serious game improves first aid knowledge in high school students aged 14 to 17 years compared with classic first aid education and with an attention control session.
The main questions it aims to answer are:
- Does first aid education delivered through a mobile serious game increase first aid knowledge compared with an attention control session?
- Does classic first aid education increase first aid knowledge compared with an attention control session?
- Is there a difference in first aid knowledge between students who learn through the mobile game and students who receive classic education?
Participating students are randomly assigned, within their grade level, to one of three arms:
- Mobile game arm: students learn first aid individually through an Android-based serious game.
- Classic education arm: students receive standardized first aid education covering the same learning objectives.
- Attention control arm: students receive a nutrition education session on reading food labels, unrelated to first aid, and receive first aid education after the study.
Before the session, all students complete a short questionnaire and a first aid knowledge test in their allocated room. All three sessions last about 8 to 10 minutes and take place at the same time in separate rooms on a single day. All students complete the same first aid knowledge test again immediately after the session.
Descripción general del estudio
Estado
Descripción detallada
Design: Three-arm, parallel-group, stratified randomized controlled trial with a pretest-posttest design and outcome-assessor blinding, reported according to CONSORT 2025.
Interventions: (1) "CanKurtaranKahraman" mobile serious game covering the Protection-Notification-Rescue sequence, characteristics of the first aider, information to give the 112 emergency call centre, basic first aid definitions, and the chain of survival, with immediate written feedback; each student plays individually on a separate device; (2) classic education delivered by a certified first aid instructor to the whole arm at once, with standardized scripted content covering the same learning objectives; (3) an attention control session on reading food labels, delivered by an experienced dietitian to the whole arm at once with a standardized script. Planned duration is 8-10 minutes in all three arms. All arms are delivered simultaneously in separate rooms on a single day to minimize contamination.
Randomization: Individual 1:1:1 allocation, stratified by grade level (9th, 10th, 11th, 12th), using permuted blocks of variable size (3 and 6). The computer-generated sequence is produced by an independent faculty member not involved in recruitment, intervention delivery, outcome assessment, or analysis. On the day of the study, after attendance is taken and before the baseline test, the same person applies the sequence to the list of participant codes in a prespecified order (central allocation), so that allocation remains concealed from the investigator. Students go directly to their allocated room and complete the baseline test there; the rooms are similar, no study materials are present, and intervention providers enter only after the baseline tests are collected.
Blinding: Students and intervention providers cannot be blinded. Test scoring, data entry, and statistical analysis are performed by personnel blinded to group allocation, using coded group labels.
Sample size: The sample size was calculated with G*Power 3.1 for ANCOVA (fixed effects, planned contrast, numerator df = 1, 3 groups, 2 covariates) for the primary comparison (mobile game vs attention control). Based on meta-analytic evidence on digital serious games for knowledge outcomes (pooled SMD 0.66 overall; 0.43 for single-session interventions), an effect size of d = 0.5 was assumed (f = 0.236 after adjustment for a pretest-posttest correlation of r = 0.50), with a two-sided alpha of 0.05 and 80% power. The required sample is 48 students per arm (144 in total). Allowing for 15% attrition, at least 171 students (57 per arm) will be randomized. The comparison between the mobile game and classic education is a secondary comparison and will be reported as an effect estimate with a 95% confidence interval.
Statistical analysis: The primary analysis is ANCOVA with the posttest knowledge score as the dependent variable, study arm as the factor, and the pretest score and grade level (stratification factor) as covariates. Hypotheses are tested in a fixed sequence at alpha = 0.05: (1) mobile game vs attention control (primary), (2) classic education vs attention control, (3) mobile game vs classic education (secondary; interpreted mainly through the adjusted mean difference and its 95% confidence interval). Adjusted mean differences with 95% confidence intervals and Hedges' g are reported. The primary analysis follows the intention-to-treat principle with multiple imputation for missing posttest data; complete-case and per-protocol analyses are performed as sensitivity analyses.
Pilot: A pilot with 24 students (3 girls and 3 boys from each grade, randomly selected among consenting students) is conducted one day before the main study, using the same procedures and a separate allocation list, to test feasibility and timing. Pilot participants are excluded from the main study.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cumhur Babaoğlu, MSc
- Número de teléfono: +90 554 927 6841
- Correo electrónico: cumhur.babaoglu@bilecik.edu.tr
Ubicaciones de estudio
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Bilecik
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Bilecik, Bilecik, Turquía (Türkiye)
- 15 Temmuz Sehitler Anadolu Lisesi
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Contacto:
- Cumhur Babaoğlu, MSc
- Número de teléfono: +90 554 927 6841
- Correo electrónico: cumhur.babaoglu@bilecik.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Enrolled in grades 9-12 at the participating high school
- Aged 14-17 years
- Written informed consent from a parent or legal guardian
- Written assent from the student
- Able to read Turkish and use a touchscreen device
Exclusion Criteria:
- Holding a first aid certificate approved by the Ministry of Health
- Visual, hearing, or motor impairment that prevents use of the mobile game or completion of the test
- Participation in the pilot study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mobile Serious Game
Students learn first aid individually through the "CanKurtaranKahraman" Android-based mobile serious game with immediate feedback, each on a separate device (approximately 8-10 minutes). |
Android-based mobile serious game ("CanKurtaranKahraman") in which students complete scenario-based tasks on basic first aid topics, including the Protection-Notification-Rescue sequence, characteristics of the first aider, calling the 112 emergency call centre, basic first aid definitions, and the chain of survival, with immediate written feedback.
Otros nombres:
|
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Comparador activo: Classic First Aid Education
A certified first aid instructor delivers standardized, scripted first aid education (lecture with questions and answers) covering the same learning objectives as the mobile game to the whole arm at once (approximately 8-10 minutes). |
Scripted lecture followed by a short question-and-answer section, delivered by a certified first aid instructor and covering the same learning objectives as the mobile game. No video, manikin, hands-on practice, or printed materials are used. |
|
Comparador falso: Attention Control
An experienced dietitian delivers a standardized, scripted nutrition education session on reading food labels, unrelated to first aid, to the whole arm at once (approximately 8-10 minutes). After the posttest, students in this arm receive first aid education. |
Scripted session on reading food labels delivered by an experienced dietitian, matched to the intervention arms in duration and format, with no first aid content. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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First aid knowledge score
Periodo de tiempo: Baseline and Day 1 (immediately after the 8-10 minute intervention)
|
Total score on the General First Aid Knowledge Level Questionnaire (GİYBSF), a 20-item multiple-choice test (score range 0-20; higher scores indicate greater knowledge). Analyzed as the posttest score adjusted for the pretest score and grade level (ANCOVA). |
Baseline and Day 1 (immediately after the 8-10 minute intervention)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ayşe Çevirme, Phd (Prof. Dr.), Sakarya University
- Investigador principal: Cumhur Babaoğlu, MSc, Sakarya University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SAU-SBBAEK-212
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data underlying the published results, a data dictionary, and the analysis code will be shared upon reasonable request and with the approval of the principal investigator.
Marco de tiempo para compartir IPD
Beginning after publication of the primary results and available for 5 years.
Criterios de acceso compartido de IPD
Researchers who submit a methodologically sound proposal to the principal investigator by email; data will be shared after approval by the principal investigator and signing of a data use agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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