- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06929715
Effect of an Educational Intervention on CPR Knowledge and Skills in Schoolchildren
Effect of an Educational Intervention on CPR Knowledge and Skills in 7- and 8-Year-Old Schoolchildren: A Non-Randomized Controlled Trial
This study aims to evaluate the effectiveness of a CPR intervention for children aged 7 and 8. Given the high prevalence of out-of-hospital cardiac arrests (OHCA) and the proven benefits of early CPR training, the study seeks to determine whether a structured intervention can improve young children's knowledge and skills in basic life support.
What is the effect of a CPR training intervention on the knowledge and skills of 7- and 8-year-old schoolchildren?
Cardiac arrest is a leading cause of mortality worldwide. Research shows that survival rates increase significantly when CPR is performed promptly by a trained bystander. Countries with early CPR training programs in schools, such as Norway and Denmark, report better survival outcomes. However, in Latin America, CPR education in schools is still in its early stages. Evidence suggests that children can effectively learn and retain CPR knowledge, and they can serve as multipliers by passing their knowledge to family and peers.
Study Design:
This is a non-randomized, double-blind controlled trial with four phases:
Study Overview
Status
Conditions
Detailed Description
Intervention Design - Developing an age-appropriate CPR training intervention based on educational and cognitive development theories.
Content Validation - Experts in child education and health professionals will assess the content and delivery methods.
Validation of Assessment Tools - Ensuring reliability in measuring children's CPR knowledge and skills.
Intervention Implementation and Evaluation - The intervention will be conducted in schools, with pre- and post-tests assessing knowledge and skills retention after 3 months.
Expected Outcomes:
Improved knowledge and skill levels in CPR among children who receive the intervention.
Validation of a structured educational approach for teaching CPR to young children.
Contribution to global evidence on CPR education and its potential impact in Bogotá schools.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diana M Blanco-Avila, Master of Nursing
- Phone Number: +573115616350
- Email: dmblancoa@unal.edu.co
Study Locations
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Distrito Capital
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Bogotá, Distrito Capital, Colombia, 111321
- Universidad Nacional de Colombia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Schoolchildren aged between 7 and 8 years.
- Students enrolled in an educational institution that has authorized their participation in the study.
- Not participating in any other intervention or educational program related to CPR during the study period.
Exclusion Criteria:
- Students whose parents, legal guardians, teachers, or the students themselves report any health condition that prevents them from participating in the study.
- Students who indicate having received prior training in CPR or related skills.
- Students whose parents, legal guardians, or teachers report any cognitive condition that limits their ability to understand and follow the instructions necessary to learn and practice CPR in simulated scenarios.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Arm
This group of students receives the structured educational program designed to teach the first link in the chain of survival, specifically tailored for their age.
The intervention is delivered in the school setting and focuses on enhancing the knowledge and practical CPR skills of 7- and 8-year-old children.
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Unlike traditional CPR training programs designed primarily for older children or adults, this intervention is uniquely tailored for 7- and 8-year-old schoolchildren.
It employs a narrative-based, age-appropriate educational approach that incorporates storytelling, interactive activities, and practical simulation exercises aligned with the cognitive and motor development of young learners.
Delivered by school nurses in a classroom setting, the program not only focuses on teaching the first link in the chain of survival but also ensures that its content and methods are rigorously validated by experts.
Moreover, the intervention includes a follow-up evaluation at three months to assess the retention of knowledge and skills, distinguishing it from other clinical studies that lack such long-term assessment.
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Placebo Comparator: Control Arm
This group does not receive the CPR educational intervention during the study period but will receive a first aid intervention that does not include teaching the first link in the chain of survival.
This group serves as a reference to compare and evaluate the effectiveness of the program implemented in the intervention group.
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In the control arm, participants receive a structured first aid educational program that intentionally excludes any training on the first link in the chain of survival.
This intervention focuses on general first aid skills-such as wound care, management of minor injuries, and other non-cardiac emergency procedures-ensuring that no content related to recognizing a cardiac emergency or activating the emergency response system is provided.
Delivered in a classroom setting by qualified personnel, the program is designed to mirror the overall structure, duration, and engagement level of the CPR intervention without overlapping its core content.
Expert validation has been obtained to confirm that the curriculum remains neutral and strictly adheres to general first aid, thereby serving as a robust comparator to isolate the specific effects of CPR training in young schoolchildren.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge and practical skills in basic CPR-specifically, the first link in the chain of survival
Time Frame: 3 moths
|
The primary outcome measure for this study is the change in knowledge and practical skills in basic CPR-specifically, the first link in the chain of survival-among 7- and 8-year-old schoolchildren.
This will be assessed through a structured pre- and post-intervention questionnaire that evaluates theoretical understanding of CPR and an observational checklist used during simulated scenarios to gauge practical skill execution.
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3 moths
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wissenberg M, Lippert FK, Folke F, Weeke P, Hansen CM, Christensen EF, Jans H, Hansen PA, Lang-Jensen T, Olesen JB, Lindhardsen J, Fosbol EL, Nielsen SL, Gislason GH, Kober L, Torp-Pedersen C. Association of national initiatives to improve cardiac arrest management with rates of bystander intervention and patient survival after out-of-hospital cardiac arrest. JAMA. 2013 Oct 2;310(13):1377-84. doi: 10.1001/jama.2013.278483.
- Pedrazas-Lopez D, de Pablo-Marquez B, Cunillera-Puertolas O, Almeda-Ortega J; Grupo de Investigacion RCParvulari. RCParvulari training: A basic life support training methodology applied to 5-year-old students: Effectiveness in a cluster-randomized clinical trail. An Pediatr (Engl Ed). 2023 Feb;98(2):99-108. doi: 10.1016/j.anpede.2023.01.006. Epub 2023 Feb 3.
- Nakagawa NK, Salles IC, Semeraro F, Bottiger BW. KIDS SAVE LIVES: a narrative review of associated scientific production. Curr Opin Crit Care. 2021 Dec 1;27(6):623-636. doi: 10.1097/MCC.0000000000000872.
- Navarro-Paton R, Freire-Tellado M, Fernandez-Gonzalez N, Basanta-Camino S, Mateos-Lorenzo J, Lago-Ballesteros J. What is the best position to place and re-evaluate an unconscious but normally breathing victim? A randomised controlled human simulation trial on children. Resuscitation. 2019 Jan;134:104-109. doi: 10.1016/j.resuscitation.2018.10.030. Epub 2018 Oct 30.
- Stroobants J, Monsieurs K, Devriendt B, Dreezen C, Vets P, Mols P. Schoolchildren as BLS instructors for relatives and friends: Impact on attitude towards bystander CPR. Resuscitation. 2014 Dec;85(12):1769-74. doi: 10.1016/j.resuscitation.2014.10.013.
- Ong ME, Shin SD, De Souza NN, Tanaka H, Nishiuchi T, Song KJ, Ko PC, Leong BS, Khunkhlai N, Naroo GY, Sarah AK, Ng YY, Li WY, Ma MH; PAROS Clinical Research Network. Outcomes for out-of-hospital cardiac arrests across 7 countries in Asia: The Pan Asian Resuscitation Outcomes Study (PAROS). Resuscitation. 2015 Nov;96:100-8. doi: 10.1016/j.resuscitation.2015.07.026. Epub 2015 Jul 30. Erratum In: Resuscitation. 2016 Jan;98:125-6.
- De Buck E, Van Remoortel H, Dieltjens T, Verstraeten H, Clarysse M, Moens O, Vandekerckhove P. Evidence-based educational pathway for the integration of first aid training in school curricula. Resuscitation. 2015 Sep;94:8-22. doi: 10.1016/j.resuscitation.2015.06.008. Epub 2015 Jun 18.
- Suss-Havemann C, Kosan J, Seibold T, Dibbern NM, Daubmann A, Kubitz JC, Beck S. Implementation of Basic Life Support training in schools: a randomised controlled trial evaluating self-regulated learning as alternative training concept. BMC Public Health. 2020 Jan 13;20(1):50. doi: 10.1186/s12889-020-8161-7.
- Yeung J, Kovic I, Vidacic M, Skilton E, Higgins D, Melody T, Lockey A. The school Lifesavers study-A randomised controlled trial comparing the impact of Lifesaver only, face-to-face training only, and Lifesaver with face-to-face training on CPR knowledge, skills and attitudes in UK school children. Resuscitation. 2017 Nov;120:138-145. doi: 10.1016/j.resuscitation.2017.08.010. Epub 2017 Oct 1.
- Bohn A, Van Aken H, Lukas RP, Weber T, Breckwoldt J. Schoolchildren as lifesavers in Europe - training in cardiopulmonary resuscitation for children. Best Pract Res Clin Anaesthesiol. 2013 Sep;27(3):387-96. doi: 10.1016/j.bpa.2013.07.002.
- Universidad Nacional de Colombia - Sede Bogotá, Enfermería F de. Avances de investigación en la Facultad de Enfermería. Editorial. Vol. 1, Editorial Universidad Nacional de Colombia. 2022. 1-426 p.
- Malta Hansen C, Kragholm K, Pearson DA, Tyson C, Monk L, Myers B, Nelson D, Dupre ME, Fosbol EL, Jollis JG, Strauss B, Anderson ML, McNally B, Granger CB. Association of Bystander and First-Responder Intervention With Survival After Out-of-Hospital Cardiac Arrest in North Carolina, 2010-2013. JAMA. 2015 Jul 21;314(3):255-64. doi: 10.1001/jama.2015.7938.
- Plant N, Taylor K. How best to teach CPR to schoolchildren: a systematic review. Resuscitation. 2013 Apr;84(4):415-21. doi: 10.1016/j.resuscitation.2012.12.008. Epub 2012 Dec 11.
- Bottiger BW, Lockey A, Aickin R, Castren M, de Caen A, Escalante R, Kern KB, Lim SH, Nadkarni V, Neumar RW, Nolan JP, Stanton D, Wang TL, Perkins GD. "All citizens of the world can save a life" - The World Restart a Heart (WRAH) initiative starts in 2018. Resuscitation. 2018 Jul;128:188-190. doi: 10.1016/j.resuscitation.2018.04.015. Epub 2018 Apr 19.
- Semeraro F, Greif R, Bottiger BW, Burkart R, Cimpoesu D, Georgiou M, Yeung J, Lippert F, S Lockey A, Olasveengen TM, Ristagno G, Schlieber J, Schnaubelt S, Scapigliati A, G Monsieurs K. European Resuscitation Council Guidelines 2021: Systems saving lives. Resuscitation. 2021 Apr;161:80-97. doi: 10.1016/j.resuscitation.2021.02.008. Epub 2021 Mar 24.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVAL 20-24 (Other Identifier: Universidad Nacional de Colombia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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