Basic Life Support by Children

June 18, 2020 updated by: Cristina Genzor

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

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

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zaragoza, Spain, 50009
        • Cristina Genzor Ríos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • One year basic life support training
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:
  • Two years basic life support training

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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 11, 2020

Primary Completion (ACTUAL)

February 27, 2020

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (ACTUAL)

June 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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