Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT03443167
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2018-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiopulmonary Resuscitation by Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the phase of data analysis will be masked'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicentric clinical trial based on an ad hoc questionnaire'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-05', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Learning the helpline number for emergencies (112).', 'timeFrame': 'baseline', '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.'}], 'secondaryOutcomes': [{'measure': 'Learnig the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes', 'timeFrame': 'baseline', '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.'}, {'measure': 'Improvement or maintenance of the knowledge of the helpline number for emergencies (112)', 'timeFrame': '6-12 months', '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'}, {'measure': 'Improvement or maintenance of the knowledge of the relatinoship between helpline number for emergencie to the mnemonic mouth-nose-eyes', 'timeFrame': '6-12 months', '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary Resuscitation', 'Teaching Material', 'Primary education'], 'conditions': ['Cardiopulmonary Arrest With Successful Resuscitation']}, 'referencesModule': {'references': [{'pmid': '26209417', 'type': 'BACKGROUND', '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.'}, {'type': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.elsevier.es/es-revista-medicina-general-familia-edicion-digital--231-sumario-vol-4-num-2-S1889543315X0003X', 'label': 'Martínez I 2015: Children are also carriers of knowledge among their surroundings like family or friends'}]}, 'descriptionModule': {'briefSummary': "Children's education students are able to identify a possible emergency and in their case act appropriately.\n\nThe 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.", 'detailedDescription': '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).\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spanish primary education students attending the 5th level.\n* Informed consent signed by parents or tutors\n\nExclusion Criteria:\n\n• Spanish primary school children with learning disabilities.'}, 'identificationModule': {'nctId': 'NCT03443167', 'acronym': 'RCParvulari', 'briefTitle': 'Cardiopulmonary Resuscitation by Children', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'RCParvulari: Knowledge, Attitudes and Practices on Cardiopulmonary Resuscitation (CPR) in the Infant Population.', 'orgStudyIdInfo': {'id': '4R17/094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'Training on emergency telephone numbers and mnemonics', 'interventionNames': ['Behavioral: Training on emergency telephone numbers and mnemonics']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Sham generic formation on the cardiopulmonary arrest.', 'interventionNames': ['Behavioral: Sham generic formation on the cardiopulmonary arrest.']}], 'interventions': [{'name': 'Training on emergency telephone numbers and mnemonics', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Intervention group']}, {'name': 'Sham generic formation on the cardiopulmonary arrest.', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08630', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Abrera', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'David Pedrazas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Català de la Salut. Jordi Gol i Gurina Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Pedrazas', 'investigatorAffiliation': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}}}}