- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Cumhur Babaoğlu, MSc
- Numero di telefono: +90 554 927 6841
- Email: cumhur.babaoglu@bilecik.edu.tr
Luoghi di studio
-
-
Bilecik
-
Bilecik, Bilecik, Turchia (Türkiye)
- 15 Temmuz Sehitler Anadolu Lisesi
-
Contatto:
- Cumhur Babaoğlu, MSc
- Numero di telefono: +90 554 927 6841
- Email: cumhur.babaoglu@bilecik.edu.tr
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
|
Comparatore attivo: 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. |
|
Comparatore fittizio: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
First aid knowledge score
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Ayşe Çevirme, Phd (Prof. Dr.), Sakarya University
- Investigatore principale: Cumhur Babaoğlu, MSc, Sakarya University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- SAU-SBBAEK-212
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
Beginning after publication of the primary results and available for 5 years.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .