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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04440111
Other study ID # PI19/490
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 11, 2020
Est. completion date April 2021

Study information

Verified date June 2020
Source Instituto de Investigación Sanitaria Aragón
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A controlled clinical trial will be performed.

School children from the age of 10 to 11 will be selected to learn basic life support (BLS) in a primary school of Zaragoza.

One of the groups will learn BLS in two consecutive years and the other group will learn BLS only the first year.

The investigators think that the knowledge will be better in the group that receives two interventions.


Description:

A controlled clinical trial will be performed.

72 participants between 10 and 11 years old will be selected and randomized to participate.

Control group and experimental group will enrolled 36 participants each one. Control group will receive BLS training once. Experimental group will receive BLS training in two consecutive years.

Previous and after training a test will be performed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 72
Est. completion date April 2021
Est. primary completion date February 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility Inclusion Criteria:

- Children from 10 to 12 years old that are attending to the selected school at the moment of the intervention

- Children with signed consent given by parents at the moment of the intervention

Exclusion Criteria:

- Children not attending all the theorical and practical interventions

- Children not completing all test.

- Children with learning disabilities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
One year training
At first, children will make a test to evaluate their pre- intervention basic support life knowledge. Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that, they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will only make the test, they won't receive any theory or practice.
Two years training
At first, children will make a test to evaluate their pre- intervention basic support life knowledge. Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will repeat the same process.

Locations

Country Name City State
Spain Cristina Genzor Ríos Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Cristina Genzor Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Bohn A, Lukas RP, Breckwoldt J, Böttiger BW, Van Aken H. 'Kids save lives': why schoolchildren should train in cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):220-5. doi: 10.1097/MCC.0000000000000204. — View Citation

Bohn A, Van Aken HK, Möllhoff T, Wienzek H, Kimmeyer P, Wild E, Döpker S, Lukas RP, Weber TP. Teaching resuscitation in schools: annual tuition by trained teachers is effective starting at age 10. A four-year prospective cohort study. Resuscitation. 2012 — View Citation

Böttiger BW, Van Aken H. Kids save lives--Training school children in cardiopulmonary resuscitation worldwide is now endorsed by the World Health Organization (WHO). Resuscitation. 2015 Sep;94:A5-7. doi: 10.1016/j.resuscitation.2015.07.005. Epub 2015 Jul — View Citation

Haseneder R, Skrzypczak M, Haller B, Beckers SK, Holch J, Wank C, Kochs E, Schulz CM. Impact of instructor professional background and interim retesting on knowledge and self-confidence of schoolchildren after basic life support training: a cluster random — View Citation

Lukas RP, Van Aken H, Mölhoff T, Weber T, Rammert M, Wild E, Bohn A. Kids save lives: a six-year longitudinal study of schoolchildren learning cardiopulmonary resuscitation: Who should do the teaching and will the effects last? Resuscitation. 2016 Apr;101 — View Citation

Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Böttiger 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the knowledge level of BLS after receiving one or two interventions A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015. 3 hours
Primary To compare test results obtained previous and after intervention. A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015. After obteining the marks, the results will be compared using Statistical Analysis Software. 1 month
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