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临床试验/NCT06565767
NCT06565767已完成不适用

Continuous Chest Compressions Training Among Schoolchildren With Gamification in Brazil: a Pilot Study Study Start Date November 2022

Hospital Israelita Albert Einstein2 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2022年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
336
试验地点
2
主要终点
Depth compression

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

open

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • no sign informed consent and assent.

结局指标

主要结局

Depth compression

时间窗: one hour after training

variability in compression depth among different age groups, taking into account physical attributes in millimetres

次要结局

  • Knowledge serious game(one hour after training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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