An interventional study of Mobile serious game-based first aid education and Classic first aid education in First Aid, Health Education in Schoolchildren and Adolescent Health, sponsored by Sakarya University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Sakarya University · Not applicable, Interventional, and Other
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:
Participating students are randomly assigned, within their grade level, to one of three arms:
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.
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.
481 studies on the registry are indexed under Health Education; 110 are open to participants now.
This study's planned enrollment of 171 is above the median of 132 across 450 interventional studies indexed under Health Education.
Browse Health Education studies →Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Mobile serious game-based 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).
Behavioral: Classic first aid education
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.
Behavioral: Nutrition education on food label reading (attention control)
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.
Also known as: CanKurtaranKahraman
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.
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.
First aid knowledge score
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).
Time frame: Baseline and Day 1 (immediately after the 8-10 minute intervention)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning after publication of the primary results and available for 5 years.
Access criteria: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2026, 0 months later.
Of 292 non-industry interventional studies with no phase under Health Education, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 0 months is below that.
Counting every sponsor, half of 293 studies reached it within 11 months; a quarter within 3 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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