Readiness for Basic Life Support in Schools

Cardiopulmonary Resuscitation Clinical Trial

Official title: Readiness for Basic Life Support in Schools: Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

This research is a response to problems with Cardiovascular Disease in Colombia, where circulatory system diseases are the first cause of mortality in the adult population, making them a critical issue for the country. It is known that around 70% of cardiac arrests occur outside health institutions, generally at home or on public roads.

To reduce these high mortality rates, international recommendations were issued to establish strategies to train the general population in cardiopulmonary resuscitation, especially school-age children. This constitutes a key stage for initiating learning. This condition significantly favors learning and preserving the acquired knowledge for the rest of their life.

Based on the reasons above, this pilot project seeks to be the first approach at the national level to train second-grade elementary school children in Basic Life Support. This training will describing the step by step experiences of the participants, focusing on: project viability related to recruitment and follow-up, acceptability, the experience of participation from the educational community, and the effects of implementing the intervention on the knowledge and skills in the child population. A virtual protocol will be implemented (adapted to the current situation generated by the Coronavirus pandemic), and will be developed through didactic methodologies in three 60-minute educational sessions, during regular class hours.

Clinical Trial Description

1. Research question What are the viability, acceptability, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention in two schools in the city of Tunja in 2021?

2. General objective:

To describe the viability, acceptability, participation experience, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention, in two schools in the city of Tunja in 2021.

3. Specific objectives To carry out the characterization of the child population under study. To describe the viability of the UN Lifeguard Kids in the Tunja version intervention in terms of recruitment and follow through.

To describe the acceptability of the UN Lifeguard Kids in the Tunja version intervention for the child population that receives it.

To describe the experience of participating in the UN Lifeguard Kids in the Tunja version intervention for the academic community.

To describe the effects of the UN Lifeguard Kids in the Tunja version intervention on theoretical knowledge and practical skills in the child population that receives it.

4. A sample population of 70 children was determined as appropriate for the study. Two second-graded classes were selected to fulfill this requirement. Children were assigned to a control or test group using simple random sampling. Finally, five additional children were added to reduce sample attrition.

5. Biases control

• Selection bias: It will be controlled in this study by strictly complying with the inclusion and exclusion criteria. Likewise, by applying the random blocks methodology for the allocation of the intervention and control group, guaranteeing an equitable distribution of children. Another measure is the application of the double-blind method so that neither the participants nor the research assistants responsible for measuring response variables, know which group they belong to or which intervention they received.

• Detection biases: It will be controlled by including five nursing professionals who are not part of the study to carry out the measurements.

• Attrition biases: There are two steps to control attrition. Firts, children will be motivated in each session through playful methodologies and novel didactic material, encouraging continued participation. Second, sessions will be within the usual class schedule to prevent abandonment.

• Notification bias: It will be controlled through an ethical commitment by the researcher when publishing the complete results of the interventions. Additionally, these results will be publically available through the clinicaltrial.org portal.

• Confusion biases: it will be controlled by randomization; distributing the known and unknown confounding variables equally between the groups and therefore, avoiding possible biases in the analysis. Subsequently, a comparison of the confounding variables will be made between the experimental and control groups before analyzing the response variables to identify the equivalence of the groups.

6. Statistical analysis: Descriptive statistics will be used for the analyses of the qualitative variables, through the distribution of frequencies and proportions. For continuous quantitative variables, descriptive statistics will be used with measures of central tendency (i.e. average and SD), dispersion, and 95% confidence intervals. For the intra- and inter-group comparisons of the continuous quantitative response variables, adjustment tests will be performed using the Kolgomorov Smirnov Gaussian model. If the adjustment is satisfactory, the comparisons will be made with paired Student's T-tests for intragroup and unpaired Student's T-tests for the intergroup analyses. Otherwise, Wilcoxon and Man Whitney U signed-rank tests will be performed, respectively. ;

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation
• First Aid
• Health Education

• NCT number: NCT04914871
• Study type: Interventional
• Source: Universidad Nacional de Colombia
• Contact: Luz D Cano Rodriguez, Nursing
• Phone: 313 871 9480
• Email: lucanor@unal.edu.co
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2021
• Completion date: April 1, 2022