- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440111
Basic Life Support by Children
Teaching Children Basic Life Support: Randomized Clinical Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zaragoza, Spain, 50009
- Cristina Genzor Ríos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Control group
One year basic life support 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.
Other Names:
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SHAM_COMPARATOR: Experimental group
Two years basic life support 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the knowledge level of BLS after receiving one or two interventions
Time Frame: 3 hours
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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.
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3 hours
|
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To compare test results obtained previous and after intervention.
Time Frame: 1 month
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- Bottiger 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 21. No abstract available.
- Bohn A, Van Aken HK, Mollhoff T, Wienzek H, Kimmeyer P, Wild E, Dopker 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 May;83(5):619-25. doi: 10.1016/j.resuscitation.2012.01.020. Epub 2012 Jan 28.
- Lukas RP, Van Aken H, Molhoff 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;101:35-40. doi: 10.1016/j.resuscitation.2016.01.028. Epub 2016 Feb 8.
- Bohn A, Lukas RP, Breckwoldt J, Bottiger 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.
- 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 randomised longitudinal study. Emerg Med J. 2019 Apr;36(4):239-244. doi: 10.1136/emermed-2018-207923. Epub 2019 Feb 16.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI19/490
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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