Readiness for Basic Life Support in Schools

NCT ID: NCT04914871

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-04-01

Brief 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.

Detailed 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.

Conditions

Health Education; First Aid; Cardiopulmonary Resuscitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

The experimental protocol UN Lifeguard Kids in the Tunja version

Group to which the experimental protocol will be offered.

Group Type: EXPERIMENTAL

Protocol UN Lifeguard Kids in the Tunja version

Intervention Type: BEHAVIORAL

The experimental protocol UN Lifeguard Kids in the Tunja version done by the researcher following the guidelines of International organizations such as the American Heart association and European Resuscitation Council.

The intervention consists of 3 sessions of 60 minutes of theoretical and practical exercises on BLS, developed within the usual class schedule.

Educational session, accident prevention and wound management.

The control group will be offered the Educational session.

Group Type: PLACEBO_COMPARATOR

Educational session accident prevention and wound management

Intervention Type: BEHAVIORAL

It will be provided to the control group

Interventions

Protocol UN Lifeguard Kids in the Tunja version

The experimental protocol UN Lifeguard Kids in the Tunja version done by the researcher following the guidelines of International organizations such as the American Heart association and European Resuscitation Council.

The intervention consists of 3 sessions of 60 minutes of theoretical and practical exercises on BLS, developed within the usual class schedule.

Intervention Type: BEHAVIORAL

Educational session accident prevention and wound management

It will be provided to the control group

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Seven and eight-year-old.
• Children who are in the second grade of elementary school in two schools in the city of Tunja.
• Children's families with an available computer tablet or mobile device and internet connection will be considered for the study.
• Children who have a caregiver 18 years of age or older to accompany them during the intervention.
• Children with adequate learning skills (This data will be obtained from the report of the course teacher)

Exclusion Criteria

• Children who have received a scientific intervention on CPR.
• Children who participate in a rescue force (i.e., police, civil defense, brigade members).
• Children with a diagnosis of physical or mental disability (autism spectrum disorder, trisomy 21, Asperger syndrome, Tourette syndrome, attention deficit hyperactivity disorder (ADHD), severe visual, hearing, or motor problems, and/or similar disabilities).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Nacional de Colombia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Patricia Carreño Moreno, RN, MSc, PhD

Role: STUDY_DIRECTOR

Universidad Nacional de Colombia

Central Contacts

Luz D Cano Rodriguez, Nursing

Role: CONTACT

lucanor@unal.edu.co

313 871 9480

Luz D Cano Rodriguez, Nursing

Role: CONTACT

luz.cano@uptc.edu.co

313 8719480

References

Bottiger BW, Van Aken H. Training children in cardiopulmonary resuscitation worldwide. Lancet. 2015 Jun 13;385(9985):2353. doi: 10.1016/S0140-6736(15)61099-6. No abstract available.

Reference Type: BACKGROUND

PMID: 26088639 (View on PubMed)

Yasunaga H, Horiguchi H, Tanabe S, Akahane M, Ogawa T, Koike S, Imamura T. Collaborative effects of bystander-initiated cardiopulmonary resuscitation and prehospital advanced cardiac life support by physicians on survival of out-of-hospital cardiac arrest: a nationwide population-based observational study. Crit Care. 2010;14(6):R199. doi: 10.1186/cc9319. Epub 2010 Nov 4.

Reference Type: BACKGROUND

PMID: 21050434 (View on PubMed)

Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.

Reference Type: BACKGROUND

PMID: 30098386 (View on PubMed)

Oving I, Masterson S, Tjelmeland IBM, Jonsson M, Semeraro F, Ringh M, Truhlar A, Cimpoesu D, Folke F, Beesems SG, Koster RW, Tan HL, Blom MT; ESCAPE-NET Investigators. First-response treatment after out-of-hospital cardiac arrest: a survey of current practices across 29 countries in Europe. Scand J Trauma Resusc Emerg Med. 2019 Dec 16;27(1):112. doi: 10.1186/s13049-019-0689-0.

Reference Type: BACKGROUND

PMID: 31842928 (View on PubMed)

Other Identifiers

46377995

Identifier Type: -

Identifier Source: org_study_id