Cardiopulmonary Resuscitation by Children (RCParvulari)

• ClinicalTrials.gov Identifier: NCT03443167
• Recruitment Status: Unknown
• First Posted: February 23, 2018
• Last Update Posted: February 23, 2018
• Sponsor: Jordi Gol i Gurina Foundation
• Information provided by (Responsible Party): David Pedrazas, Jordi Gol i Gurina Foundation

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Spain

Abrera

Barcelona, Spain, 08630

Sponsors and Collaborators

Jordi Gol i Gurina Foundation

Investigators

• Principal Investigator: David Pedrazas, PhD; Institut Català de la Salut. Jordi Gol i Gurina Foundation

More Information

Additional Information:

Böttiger BW 2015: anyone can save life with an appropriate training 

Martínez I 2015: Children are also carriers of knowledge among their surroundings like family or friends 

Publications:

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 21.

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.

• Responsible Party: David Pedrazas, Principal Investigator, Jordi Gol i Gurina Foundation
• ClinicalTrials.gov Identifier: NCT03443167
• Other Study ID Numbers: 4R17/094
• First Posted: February 23, 2018
• Last Update Posted: February 23, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Heart Arrest; Heart Diseases; Cardiovascular Diseases