Cardiopulmonary ResuscitationCSCNCT06565767
Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil: a Pilot Study
A study testing cardiopulmonary resuscitation quality in people with Cardiopulmonary Resuscitation and Educational Problems, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
This study employed a randomized cluster intervention design to evaluate differences in chest compression depth among children's groups, using active learning methodologies and serious game-based learning as part of the Kids Save Hearts Project. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation, Educational Problems
- What is being tested?
- cardiopulmonary resuscitation quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Nov 2022to 21 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- no sign informed consent and assent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil: a Pilot Study Study Start Date November 2022
This study employed a randomized cluster intervention design to evaluate differences in chest compression depth among children's groups, using active learning methodologies and serious game-based learning as part of the Kids Save Hearts Project.
Read the detailed description
A cluster randomized trial will be carried out where the distribution among groups will be conducted by block. Four hundred children from elementary and high school will be included, divided into two groups based on age: 7 to 10 years (Group I) and 11 to 17 years (Group II). The selection of groups will be performed through randomization using the Research Randomizer computer software (www.randomizer.org) among 20 schools (public and private) of the state of São Paulo, Brazil. An appropriate number of classes will be enrolled to match the sample size, considering a mean value of 20 students per class. The study will be conducted from 2022 to 2026. Schoolchildren and their legal guardians will give written informed assent and consent to participate in the study. The inclusion criteria will be enrolled in elementary or secondary school, no previous training in Basic Life Support (BLS), and signing the informed consent and assent forms. Exclusion criteria will be participants who have already had CPR training before and those who cannot attend all planned activities. CPR is not currently part of the Brazilian educational curriculum in elementary and high school institutions.The training was developed following a pattern that included: welcoming the children, obtaining demographic data (weight, height, bicep circumference, palmar strength test), qualitative evaluation of the student's expectations in a written way, evaluation of the theoretical knowledge pre-test through a Serious Game(SGT0) developed by the researchers and published previously contemplating five elements (recognition of unconsciousness, call for help, initiate fast and strong chest compressions, maintain compressions at least 100 to 120 per minute, DEA), video-based training, post-test Serious Game(SGT1), post-course written qualitative perception and evaluation for 1 minute with QCPR manikin. All participants will receive 60 minutes video-based training CPR, practicing while watching based on American Heart Association (AHA) CPR in Schools Training Kit™ and 10 minutes training with continuous chest compressions (CCC) with audio feedback. The training sessions were conducted with classes of 20 participants during the school period. Mini Little Anne Manikin (Laerdal, Norway) and Little Anne QCPR® (Laerdal Medical Inc., Stavanger, Norway) with real-time feedback software (QCPR training 4.13.3, Laerdal Medical Inc., Stavanger, Norway) were used for training. Certified Basic Life Support instructors (AHA) conducted the training based on 2020 resuscitation guidelines with a ratio of 10:1 schoolchild to instructors.Categorical variables are presented as absolute and relative frequencies. Continuous variables are presented as median with interquartile range (IQR). Comparisons will be made between the groups: group 1 (age between 7 to 10 years) versus group 2 (age between 11 to 17 years), public versus private school, female sex versus male, and QCPR score <70 versus 70. Categorical variables were compared with chi-square test or Fisher exact test when appropriate. Continuous variables were compared using independent t test or Mann-Whitney U test in case of non-normal distribution. Normality was assessed by the Kolmogorov-Smirnov test. Two-tailed tests were used, and when p <0.05, the test was considered statistically significant. All analyses were conducted using R software version 4.1.0 (R Foundation for Statistical Computing).
- Being tested
- cardiopulmonary resuscitation quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary resuscitation qualityOther
variability in compression depth among different age groups, taking into account physical attributes, through an active learning approach and game-based learning framework
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | age 7 to 11 Receives: Other: cardiopulmonary resuscitation quality |
| Group 2 | Experimental | age 11 to 17 Receives: Other: cardiopulmonary resuscitation quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth compression
variability in compression depth among different age groups, taking into account physical attributes in millimetres
Measured: one hour after training
Secondary outcomes (1)
Knowledge serious game
difference between game score before and after training CPR (minimum 0 to maximun 500)
Measured: one hour after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start10 Nov 2022
- Primary completion10 Aug 2024
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Marília, INVITARE Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565767
- Sponsor's protocol ID
- 161976
- Acronym
- CSC
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil: a Pilot Study Study Start Date November 2022
- ClinicalTrials.gov ID
- NCT06565767
- Acronym / sponsor ID
- CSC / 161976
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- University of Marília, INVITARE Institute
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study employed a randomized cluster intervention design to evaluate differences in chest compression depth among children's groups, using active learning methodologies and serious game-based learning as part of the Kids Save Hearts Project.
Detailed description
A cluster randomized trial will be carried out where the distribution among groups will be conducted by block. Four hundred children from elementary and high school will be included, divided into two groups based on age: 7 to 10 years (Group I) and 11 to 17 years (Group II). The selection of groups will be performed through randomization using the Research Randomizer computer software (www.randomizer.org) among 20 schools (public and private) of the state of São Paulo, Brazil. An appropriate number of classes will be enrolled to match the sample size, considering a mean value of 20 students per class. The study will be conducted from 2022 to 2026. Schoolchildren and their legal guardians will give written informed assent and consent to participate in the study. The inclusion criteria will be enrolled in elementary or secondary school, no previous training in Basic Life Support (BLS), and signing the informed consent and assent forms. Exclusion criteria will be participants who have already had CPR training before and those who cannot attend all planned activities. CPR is not currently part of the Brazilian educational curriculum in elementary and high school institutions.The training was developed following a pattern that included: welcoming the children, obtaining demographic data (weight, height, bicep circumference, palmar strength test), qualitative evaluation of the student's expectations in a written way, evaluation of the theoretical knowledge pre-test through a Serious Game(SGT0) developed by the researchers and published previously contemplating five elements (recognition of unconsciousness, call for help, initiate fast and strong chest compressions, maintain compressions at least 100 to 120 per minute, DEA), video-based training, post-test Serious Game(SGT1), post-course written qualitative perception and evaluation for 1 minute with QCPR manikin. All participants will receive 60 minutes video-based training CPR, practicing while watching based on American Heart Association (AHA) CPR in Schools Training Kit™ and 10 minutes training with continuous chest compressions (CCC) with audio feedback. The training sessions were conducted with classes of 20 participants during the school period. Mini Little Anne Manikin (Laerdal, Norway) and Little Anne QCPR® (Laerdal Medical Inc., Stavanger, Norway) with real-time feedback software (QCPR training 4.13.3, Laerdal Medical Inc., Stavanger, Norway) were used for training. Certified Basic Life Support instructors (AHA) conducted the training based on 2020 resuscitation guidelines with a ratio of 10:1 schoolchild to instructors.Categorical variables are presented as absolute and relative frequencies. Continuous variables are presented as median with interquartile range (IQR). Comparisons will be made between the groups: group 1 (age between 7 to 10 years) versus group 2 (age between 11 to 17 years), public versus private school, female sex versus male, and QCPR score <70 versus 70. Categorical variables were compared with chi-square test or Fisher exact test when appropriate. Continuous variables were compared using independent t test or Mann-Whitney U test in case of non-normal distribution. Normality was assessed by the Kolmogorov-Smirnov test. Two-tailed tests were used, and when p <0.05, the test was considered statistically significant. All analyses were conducted using R software version 4.1.0 (R Foundation for Statistical Computing).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: cardiopulmonary resuscitation qualityage 7 to 11 |
| Group 2 | Experimental | Other: cardiopulmonary resuscitation qualityage 11 to 17 |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- no sign informed consent and assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary resuscitation qualityvariability in compression depth among different age groups, taking into account physical attributes, through an active learning approach and game-based learning framework | Other | Group 1, Group 2 |
Primary outcome
Depth compression
Time frame: one hour after training
variability in compression depth among different age groups, taking into account physical attributes in millimetres
1 secondary outcome
Knowledge serious game
Time frame: one hour after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary resuscitation quality in people with Cardiopulmonary Resuscitation and Educational Problems, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth compression (time frame: one hour after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.