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Cardiopulmonary Resuscitation by Children (RCParvulari)

Primary Purpose

Cardiopulmonary Arrest With Successful Resuscitation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Training on emergency telephone numbers and mnemonics
Sham generic formation on the cardiopulmonary arrest.
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiopulmonary Arrest With Successful Resuscitation focused on measuring Cardiopulmonary Resuscitation, Teaching Material, Primary education

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Abrera

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

Training on emergency telephone numbers and mnemonics

Sham generic formation on the cardiopulmonary arrest.

Outcomes

Primary Outcome Measures

Learning the helpline number for emergencies (112).
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

Learnig the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes
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.
Improvement or maintenance of the knowledge of the helpline number for emergencies (112)
Number of children who mantain or improve the knowledge of the helpline number for emergencies (112), through ad hoc questionnaire, after 6-12 months
Improvement or maintenance of the knowledge of the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes
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

Full Information

First Posted
January 31, 2018
Last Updated
July 5, 2022
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT03443167
Brief Title
Cardiopulmonary Resuscitation by Children
Acronym
RCParvulari
Official Title
RCParvulari: Knowledge, Attitudes and Practices on Cardiopulmonary Resuscitation (CPR) in the Infant Population.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest With Successful Resuscitation
Keywords
Cardiopulmonary Resuscitation, Teaching Material, Primary education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicentric clinical trial based on an ad hoc questionnaire
Masking
Outcomes Assessor
Masking Description
Only the phase of data analysis will be masked
Allocation
Randomized
Enrollment
1327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Training on emergency telephone numbers and mnemonics
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham generic formation on the cardiopulmonary arrest.
Intervention Type
Behavioral
Intervention Name(s)
Training on emergency telephone numbers and mnemonics
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham generic formation on the cardiopulmonary arrest.
Intervention Description
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 Measure Information:
Title
Learning the helpline number for emergencies (112).
Description
Number of children who know the helpline number for emergencies (112),through ad hoc questionnaire, at baseline before and after intervention or sham formation.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Learnig the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes
Description
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.
Time Frame
baseline
Title
Improvement or maintenance of the knowledge of the helpline number for emergencies (112)
Description
Number of children who mantain or improve the knowledge of the helpline number for emergencies (112), through ad hoc questionnaire, after 6-12 months
Time Frame
6-12 months
Title
Improvement or maintenance of the knowledge of the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes
Description
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
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pedrazas, PhD
Organizational Affiliation
Institut Català de la Salut. Jordi Gol i Gurina Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abrera
City
Barcelona
ZIP/Postal Code
08630
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26209417
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
http://www.elsevier.es/es-revista-medicina-general-familia-edicion-digital--231-sumario-vol-4-num-2-S1889543315X0003X
Description
Martínez I 2015: Children are also carriers of knowledge among their surroundings like family or friends

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Cardiopulmonary Resuscitation by Children

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