Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565767
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil a Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil a Pilot Study Study Start Date November 2022
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSC
Brief Summary:
This study employed a randomized cluster intervention design to evaluate differences in chest compression depth among childrens 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 wwwrandomizerorg 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 institutionsThe 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 students expectations in a written way evaluation of the theoretical knowledge pre-test through a Serious GameSGT0 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 GameSGT1 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 4133 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 101 schoolchild to instructorsCategorical 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 005 the test was considered statistically significant All analyses were conducted using R software version 410 R Foundation for Statistical Computing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None