- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06565767
Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil: a Pilot Study (CSC)
August 25, 2025 updated by: Hospital Israelita Albert Einstein
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
336
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
São Paulo, São Paulo, Brazil, 05411000
- Uri Adrian Prync Flato
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
- a scientific cooperation agreement with university,
- being enrolled in elementary or secondary school
- no previous training in Basic Life Support (BLS)
Exclusion Criteria:
- no sign informed consent and assent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
age 7 to 11
|
variability in compression depth among different age groups, taking into account physical attributes, through an active learning approach and game-based learning framework
|
|
Experimental: Group 2
age 11 to 17
|
variability in compression depth among different age groups, taking into account physical attributes, through an active learning approach and game-based learning framework
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depth compression
Time Frame: one hour after training
|
variability in compression depth among different age groups, taking into account physical attributes in millimetres
|
one hour after training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge serious game
Time Frame: one hour after training
|
difference between game score before and after training CPR (minimum 0 to maximun 500)
|
one hour after training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2022
Primary Completion (Actual)
August 10, 2024
Study Completion (Actual)
August 21, 2025
Study Registration Dates
First Submitted
August 6, 2024
First Submitted That Met QC Criteria
August 19, 2024
First Posted (Actual)
August 22, 2024
Study Record Updates
Last Update Posted (Estimated)
September 2, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 161976
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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