Cardiopulmonary Arrest With Successful ResuscitationRCParvulariNCT03443167
Cardiopulmonary Resuscitation by Children
A study testing Training on emergency telephone numbers and mnemonics in people with Cardiopulmonary Arrest With Successful Resuscitation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Arrest With Successful Resuscitation
- What is being tested?
- Training on emergency telephone numbers and mnemonics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,327 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Spanish primary education students attending the 5th level.
- Informed consent signed by parents or tutors
Who cannot join
- Spanish primary school children with learning disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RCParvulari: Knowledge, Attitudes and Practices on Cardiopulmonary Resuscitation (CPR) in the Infant Population.
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.
Read the 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.
- Being tested
- Training on emergency telephone numbers and mnemonics, Sham generic formation on the cardiopulmonary arrest.
- Keywords
- Cardiopulmonary Resuscitation, Teaching Material, Primary education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on emergency telephone numbers and mnemonicsBehavioural
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 generic formation on the cardiopulmonary arrest.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Training on emergency telephone numbers and mnemonics Receives: Behavioral: Training on emergency telephone numbers and mnemonics |
| Control group | Sham comparator | Sham generic formation on the cardiopulmonary arrest. Receives: Behavioral: Sham generic formation on the cardiopulmonary arrest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (3)
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.
Measured: baseline
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
Measured: 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
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start25 Jan 2018
- Primary completion30 Mar 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary Arrest With Successful ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentric clinical trial based on an ad hoc questionnaire
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Pedrazas, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- David Pedrazas, PhD, Principal investigator, Institut Català de la Salut. Jordi Gol i Gurina Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443167
- Sponsor's protocol ID
- 4R17/094
- Acronym
- RCParvulari
- Status last verified
- Jul 2022
- First submitted
- 31 Jan 2018
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26209417Martínez 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCParvulari: Knowledge, Attitudes and Practices on Cardiopulmonary Resuscitation (CPR) in the Infant Population.
- ClinicalTrials.gov ID
- NCT03443167
- Acronym / sponsor ID
- RCParvulari / 4R17/094
- Keywords
- Cardiopulmonary Resuscitation, Teaching Material, Primary education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,327 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- multicentric clinical trial based on an ad hoc questionnaire
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Training on emergency telephone numbers and mnemonicsTraining on emergency telephone numbers and mnemonics |
| Control group | Sham comparator | Behavioral: Sham generic formation on the cardiopulmonary arrest.Sham generic formation on the cardiopulmonary arrest. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Spanish primary education students attending the 5th level.
- Informed consent signed by parents or tutors
Key exclusion criteria (1 listed)
- Spanish primary school children with learning disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on emergency telephone numbers and mnemonicsThe 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. | Behavioural | Intervention group |
| 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. | Behavioural | Control group |
Primary outcome
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.
3 secondary outcomes
Learnig the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes
Time frame: baseline
Improvement or maintenance of the knowledge of the helpline number for emergencies (112)
Time frame: 6-12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 26209417Bottiger 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.
- BackgroundMartínez 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.
- Martínez I 2015: Children are also carriers of knowledge among their surroundings like family or friendsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pedrazas, PhD principal investigator
Institut Català de la Salut. Jordi Gol i Gurina Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on emergency telephone numbers and mnemonics in people with Cardiopulmonary Arrest With Successful Resuscitation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning the helpline number for emergencies (112). (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.