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Cardiopulmonary Resuscitation by Children (RCParvulari)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03443167
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
David Pedrazas, Jordi Gol i Gurina Foundation

Brief Summary:

Children's education students are able to identify a possible emergency and in their case act appropriately.

The authors think that the propsed training will improve the knowledge, change the attitude and improve their practical skills, and also retain the information over time.


Condition or disease Intervention/treatment Phase
Cardiopulmonary Arrest With Successful Resuscitation Behavioral: Training on emergency telephone numbers and mnemonics Behavioral: Sham generic formation on the cardiopulmonary arrest. Not Applicable

Detailed Description:

Cardiopulmonary Resuscitation (CPR) formation in children and teachers is a current and high impact topic in public health: with an appropriate training anyone can save life (Böttiger, 2015). Primary school students are willing to learn CPR and they are also Carriers of knowledge among their surroundings like family or friends (Martínez, 2015).

The authors propose a clinical trial to evaluate the knowledge, attitudes and skills in primary education students of various schools, before and after a CPR formation.

The schools will be previously randomized in intervention group and control group. Once the intervention has been completed and the results obtained, training equal to the intervention will be offered to the control schools. In the bibliographic search no validated questionnaires in CPR learning among primary education students has been found.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicentric clinical trial based on an ad hoc questionnaire
Masking: Single (Outcomes Assessor)
Masking Description: Only the phase of data analysis will be masked
Primary Purpose: Supportive Care
Official Title: RCParvulari: Knowledge, Attitudes and Practices on Cardiopulmonary Resuscitation (CPR) in the Infant Population.
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR Cardiac Arrest

Arm Intervention/treatment
Active Comparator: Intervention group
Training on emergency telephone numbers and mnemonics
Behavioral: Training on emergency telephone numbers and mnemonics
The intervention will consist in carrying out an initial theoretical training on how to act in case of attending an emergency, with graphic support of slides (power-point) during 5 minutes, followed by a practical part with the projection of the video of a song and with a "role play" activity for 15 minutes, to remember the helpline number for emergencies (112) and relate it to the mnemonic mouth-nose-eyes. At the beginning and at the end of the theoretical-practical activity, the evaluation questionnaires will be administered to each one of the students.

Sham Comparator: Control group
Sham generic formation on the cardiopulmonary arrest.
Behavioral: Sham generic formation on the cardiopulmonary arrest.
The sham intervention for the control group will consist in providing a generic formation on the cardiopulmonary arrest, with graphic support of slides (power-point) during 10 minutes, without specifying the telephone number of assistance for emergencies or the mnemonics mouth-nose-eyes. At the beginning and at the end of the theoretical activity, the evaluation questionnaires will be administered to each one of the students.




Primary Outcome Measures :
  1. Learning the helpline number for emergencies (112). [ Time Frame: baseline ]
    Number of children who know the helpline number for emergencies (112),through ad hoc questionnaire, at baseline before and after intervention or sham formation.


Secondary Outcome Measures :
  1. Learnig the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes [ Time Frame: baseline ]
    Number of children who know the relatinoship between helpline number for emergencies to the mnemonic mouth-nose-eyes, through ad hoc questionnaire, at baseline before and after intervention or sham formation.

  2. Improvement or maintenance of the knowledge of the helpline number for emergencies (112) [ Time Frame: 6-12 months ]
    Number of children who mantain or improve the knowledge of the helpline number for emergencies (112), through ad hoc questionnaire, after 6-12 months

  3. Improvement or maintenance of the knowledge of the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes [ Time Frame: 6-12 months ]
    Number of children who who mantain or improve the knowledge of the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes, through ad hoc questionnaire, after 6-12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Spanish primary education students attending the 5th level.
  • Informed consent signed by parents or tutors

Exclusion Criteria:

• Spanish primary school children with learning disabilities.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443167


Locations
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Spain
Abrera
Barcelona, Spain, 08630
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
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Principal Investigator: David Pedrazas, PhD Institut Català de la Salut. Jordi Gol i Gurina Foundation

Additional Information:
Publications:
Martínez Villegas I, Varo Caro MC, Salado Natera MI. Metodología didáctica para la en-señanza de reanimación cardiopulmonar en edad infantil. Med Gen y Fam. 2015;4(2):43-46.

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Responsible Party: David Pedrazas, Principal Investigator, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03443167     History of Changes
Other Study ID Numbers: 4R17/094
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Pedrazas, Jordi Gol i Gurina Foundation:
Cardiopulmonary Resuscitation
Teaching Material
Primary education

Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases