Cardiopulmonary Resuscitation and Choking Management Education for Caregivers of Infants Under 1 Year: Comparison Between Practical Workshop and Informational Leaflet
Effectiveness of an Educational Intervention on Basic Life Support for Caregivers of Infants Under 1 Year: a Crossover Clinical Trial
Objective: to evaluate the effectiveness of an educational workshop versus standard information in improving knowledge and perceived self-efficacy in basic life support.
Study Design: randomized crossover clinical trial with two intervention periods and a one-month washout.
Methods:
- Participants: Parents, caregivers, or legal guardians of infants under 6 months of age attending well-child check-ups at three primary care centers in Cantabria.
- Interventions: Participants will be randomly assigned to two sequences: group AB will first receive intervention A (an explained information leaflet) followed by intervention B (a theoretical-practical workshop); group BA will follow the reverse order.
- Randomization: Allocation sequence concealed using sequentially numbered, opaque sealed envelopes.
- Blinding: Outcome assessors were blinded to group allocation; participants and those delivering the interventions were not.
- Implications for practice: Planned implementation of practical workshops in childcare to enhance family responses to life-threatening pediatric emergencies.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Cantabria
-
Santander, Cantabria, Španělsko, 39008
- Marqués de Valdecilla University Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion criteria:
- Being a parent or close relative of an infant under 6 months of age
- Belonging to the assigned population of one of the selected primary care centers (Bezana, El Alisal, Puente San Miguel)
- Providing written informed consent
Exclusion criteria:
-Previous experience or formal training in pediatric cardiopulmonary resuscitation (accredited courses or undergraduate training)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Group AB: Explained information sheet + theoretical-practical workshop
Delivery and explanation during consultation of an informational sheet on management of choking in infants under 1 year, based on ERC guidelines.
The intervention includes minimal theoretical instruction without mannequin practice.
After the explanation, the date for the practical workshop is provided.
|
It consisted of the delivery and brief explanation of an informational sheet on how to respond to a choking episode in infants, based on the current recommendations of the European Resuscitation Council (ERC).
This information is part of the standard content provided to families during the six-month check-up at Health Centers, within the framework of the Child Health Program of the Autonomous Community of Cantabria.
It should be noted that the sheet focuses exclusively on actions to take in case of choking, as the program does not include instruction on CPR.
It consisted of a training workshop. Each session lasted 60 to 90 minutes, with a maximum of 13 participants per group, and was conducted by three pediatric resident nurses who remained constant across all sessions to ensure consistency. The workshop was structured in two parts: -Theoretical: The content was organized into two blocks: Choking: most common causes, primary prevention, and management guidelines for a choking episode in infants. Pediatric CPR: identification of cardiopulmonary arrest (CPA), CPR sequence and guidelines, and appropriate moments to alert emergency services. -Practical: Participants were divided into three subgroups, each guided by a nurse and using a pediatric simulation manikin. Each participant individually completed a practical case of choking that progressed to CPA. |
|
Aktivní komparátor: Group BA: theoretical-practical workshop + explanation of informational sheet
60-90 minute workshop with theoretical and practical sections.
It includes a presentation of key concepts and individual practice using a pediatric manikin simulating choking and cardiopulmonary arrest, following ERC recommendations.
Each participant performs the practical cases guided by pediatric resident nurses.
After completing the workshop, the date for the explanation of the informational sheet is indicated.
|
It consisted of the delivery and brief explanation of an informational sheet on how to respond to a choking episode in infants, based on the current recommendations of the European Resuscitation Council (ERC).
This information is part of the standard content provided to families during the six-month check-up at Health Centers, within the framework of the Child Health Program of the Autonomous Community of Cantabria.
It should be noted that the sheet focuses exclusively on actions to take in case of choking, as the program does not include instruction on CPR.
It consisted of a training workshop. Each session lasted 60 to 90 minutes, with a maximum of 13 participants per group, and was conducted by three pediatric resident nurses who remained constant across all sessions to ensure consistency. The workshop was structured in two parts: -Theoretical: The content was organized into two blocks: Choking: most common causes, primary prevention, and management guidelines for a choking episode in infants. Pediatric CPR: identification of cardiopulmonary arrest (CPA), CPR sequence and guidelines, and appropriate moments to alert emergency services. -Practical: Participants were divided into three subgroups, each guided by a nurse and using a pediatric simulation manikin. Each participant individually completed a practical case of choking that progressed to CPA. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in the score of theoretical knowledge on pediatric basic life support (BLS) and choking management.
Časové okno: Immediately after each intervention and 1 month after the second intervention.
|
Theoretical knowledge will be assessed using an ad hoc 11-item multiple-choice questionnaire, specifically developed for this study due to the lack of validated scales aimed at caregivers of infants under one year of age in this field.
The questionnaire was based on the recommendations of the European Resuscitation Council (ERC).
Each correct answer will be awarded 1 point, with a total score ranging from 0 to 11.
The outcome will be expressed as the change in score from baseline (pretest) to post-intervention assessments.
|
Immediately after each intervention and 1 month after the second intervention.
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
- Larrea J. Estadística de atragantamientos en España 2022 - OPRA. 2024
- Djakow J, Turner NM, Skellett S, Buysse CMP, Cardona F, de Lucas N, et al.; ERC Paediatric Life Support Writing Group Collaborators. European Resuscitation Council Guidelines 2025: Paediatric Life Support. Resuscitation. 2025;215(Suppl 1):110767
- McCarrison R, Ren D, Woomer GR, Cassidy B. Evaluation of a Self-Instructional CPR Program for Parents With Children Enrolled in Community Swim Lessons. J Pediatr Health Care. 2017 May-Jun;31(3):314-319. doi: 10.1016/j.pedhc.2016.09.006. Epub 2016 Oct 19.
- Perkins GD, Graesner JT, Semeraro F, Olasveengen T, Soar J, Lott C, et al. European Resuscitation Council Guidelines 2021: Executive summary. Resuscitation. 2021;161:1-60
- Tiscar-Gonzalez V, Gastaldo D, Moreno-Casbas MT, Peter E, Rodriguez-Molinuevo A, Gea-Sanchez M. [Presence of relatives during cardiopulmonary resuscitation: Perspectives of health professionals, patients and family in the Basque Country]. Aten Primaria. 2019 May;51(5):269-277. doi: 10.1016/j.aprim.2017.12.002. Epub 2018 Mar 20. Spanish.
- Camejo M, Noboa M, Stegmann T, Moraes Morelli D. Conocimiento sobre soporte vital básico en padres de niños menores de 5 años: estudio de corte transversal. NURE Investig. 2022;(117):7.
- Ramos Santana N, Marrero Pérez CL, Martín Fumero L, Domínguez Suárez E, Alcocer Díaz L, Martín Pulido S, et al. Resultados de los cursos de reanimación cardiopulmonar básica para los padres de niños ingresados en una Unidad de Cuidados Intensivos Neonatales. Canarias Pediátrica.2013;37(1):10-3.
- Mejías AM. Reanimación cardiopulmonar básica y avanzada pediátrica. En: Protocolos diagnósticos y terapéuticos en pediatría. Madrid: Asociación Española de Pediatría; 2020. p. 31-48.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Rány a zranění
- Patologické procesy
- Nemoci dýchacích cest
- Poruchy dýchání
- Respirační nedostatečnost
- Patologické stavy, příznaky a symptomy
- Chování
- Dodržování a dodržování léčby
- Zdravotní chování
- Compliance pacienta
- Přijímání zdravotní péče pacientem
- Intervence adherence
- Adherence léků
- Respirační aspirace
- Obstrukce dýchacích cest
- Cizí těla
- Zdravotnické vzdělání
Další identifikační čísla studie
- 2025.404
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Anonymized individual participant data, including sociodemographic variables, responses from knowledge and self-efficacy questionnaires, and intervention sequence, will be available for research purposes. A data dictionary describing the coding and definition of each variable will also be provided.
Access to the data will be granted upon request, following submission of a research proposal and signing a data use agreement to ensure compliance with data protection regulations. The data will be available starting 6 months after the publication of the main study results.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Explanation of the informational sheet
-
University of Milano BicoccaIRCCS Eugenio MedeaDokončeno
-
Memorial Sloan Kettering Cancer CenterUkončenoRodiny nebo nejbližší příbuzní pacientů léčených v MSKCC pro nekutánní spinocelulární karcinomy | Horní aerodigestivní traktSpojené státy
-
Hospices Civils de LyonDokončenoAmbulantní péče | Pohotovostní služba, nemocnice | Zdravotní služby pro senioryFrancie
-
Sohag UniversityZatím nenabíráme
-
Puerta de Hierro University HospitalDokončenoPorucha pozornosti s hyperaktivitouŠpanělsko
-
Puerta de Hierro University HospitalInstituto de Salud Carlos III; Ministerio de Economía y Competitividad, Spain; Gammera Nest Technology CompanyNeznámýPorucha pozornosti s hyperaktivitouŠpanělsko
-
Kayseri City HospitalZatím nenabírámeAerobní cvičení | Primární lymfedémKrocan
-
novoGINeznámýOnemocnění tlustého střevaFrancie
-
Medizinische Hochschule Brandenburg Theodor FontaneDokončenoDěti | Chirurgie slinivky břišní
-
UCSF Benioff Children's Hospital OaklandNational Heart, Lung, and Blood Institute (NHLBI)DokončenoAnémie, srpkovitá anémieSpojené státy