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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group AB: Explained information sheet + theoretical-practical workshop | Active Comparator | 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. |
|
| Group BA: theoretical-practical workshop + explanation of informational sheet | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Explanation of the informational sheet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the score of theoretical knowledge on pediatric basic life support (BLS) and choking management. | 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. |
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Inclusion criteria:
Exclusion criteria:
-Previous experience or formal training in pediatric cardiopulmonary resuscitation (accredited courses or undergraduate training)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marqués de Valdecilla university hospital | Santander | Cantabria | 39008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Larrea J. Estadística de atragantamientos en España 2022 - OPRA. 2024 | ||
| 847061 | Background | 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. | |
| 41117571 |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2026 |
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A randomized crossover clinical trial was conducted with two intervention periods and a 1-month washout period. Each participant received both educational strategies (explained information sheet and theoretical-practical workshop) in a randomized order, forming two sequences: AB and BA.
After the first intervention, an immediate post-test was administered, followed by the second intervention and a subsequent immediate post-test, concluding with a delayed post-test after one month.
This model allowed for a direct comparison of the effectiveness of both educational strategies on knowledge and self-efficacy among parents and caregivers of infants under one year of age.
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To ensure allocation concealment, the generated sequence was implemented using sequentially numbered, opaque, sealed envelopes, each containing the assignment to one of the two possible intervention sequences. The envelopes were kept in custody until the inclusion of each participant and were opened only after the informed consent was signed. This mechanism prevented investigators or healthcare professionals from knowing the allocation prior to participant enrollment.
As this was an educational intervention study, it was not possible to blind the participants or the professionals delivering the interventions. However, outcome assessors remained blinded to the intervention order received by each participant, in order to minimize the risk of bias in data collection and analysis.
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| Theoretical-practical workshop | Behavioral | 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. |
|
| Background |
| Djakow J, Turner NM, Skellett S, Buysse CMP, Cardona F, de Lucas N, Castillo JD, Kiviranta P, Lauridsen KG, Markel F, Martinez-Mejias A, Roggen I, Biarent D; ERC Paediatric Life Support Writing Group collaborators. European Resuscitation Council Guidelines 2025 Paediatric Life Support. Resuscitation. 2025 Oct;215 Suppl 1:110767. doi: 10.1016/j.resuscitation.2025.110767. |
| 27771045 | Background | 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. |
| 33773824 | Background | Perkins GD, Graesner JT, Semeraro F, Olasveengen T, Soar J, Lott C, Van de Voorde P, Madar J, Zideman D, Mentzelopoulos S, Bossaert L, Greif R, Monsieurs K, Svavarsdottir H, Nolan JP; European Resuscitation Council Guideline Collaborators. European Resuscitation Council Guidelines 2021: Executive summary. Resuscitation. 2021 Apr;161:1-60. doi: 10.1016/j.resuscitation.2021.02.003. Epub 2021 Mar 24. |
| 29571750 | Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | Mejías AM. Reanimación cardiopulmonar básica y avanzada pediátrica. En: Protocolos diagnósticos y terapéuticos en pediatría. Madrid: Asociación Española de Pediatría; 2020. p. 31-48. |
| Apr 7, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2026 | Apr 30, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| D005547 | Foreign Bodies |
| D006266 | Health Education |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D014947 | Wounds and Injuries |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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