Cardiopulmonary Resuscitation and Choking Management Education for Caregivers of Infants Under 1 Year: Comparison Between Practical Workshop and Informational Leaflet

NCT07567638 | Completed

• 1 other identifier: 2025.404
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiopulmonary Resuscitation; Infant; Health Education; Airway Obstruction, Foreign-Body

Keywords

Cardiopulmonary Resuscitation/education; Foreign-Body Aspiration/therapy; Padres; Autoeficacia; Patient Education as Topic; Cross-Over Studies

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Behavioral: Explanation of the informational sheet; Behavioral: Theoretical-practical workshop

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.

Behavioral: Explanation of the informational sheet; Behavioral: Theoretical-practical workshop

Interventions

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.

Group AB: Explained information sheet + theoretical-practical workshop; Group BA: theoretical-practical workshop + explanation of informational sheet

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.

Group AB: Explained information sheet + theoretical-practical workshop; Group BA: theoretical-practical workshop + explanation of informational sheet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous experience or formal training in pediatric cardiopulmonary resuscitation (accredited courses or undergraduate training)

Sponsors & Collaborators

• Hospital Universitario Marqués de Valdecilla: lead

Study Sites (1)

Marqués de Valdecilla university hospital

Santander, Cantabria, 39008, Spain

Location

Related Publications (9)

• Larrea J. Estadística de atragantamientos en España 2022 - OPRA. 2024

  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.

  PMID: 847061 BACKGROUND

• 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

  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.

  PMID: 27771045 BACKGROUND

• 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

  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.

  PMID: 29571750 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.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Airway Obstruction; Foreign Bodies; Health Education; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Wounds and Injuries; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric nursing resident

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: May 5, 2026
• Study Start: November 20, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 20, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)