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

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.

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Key information

Conditions

Airway Obstruction, Foreign-Body Adherence Interventions Airway Obstruction Behavior Cardiopulmonary Resuscitation Foreign Bodies Health Behavior Health Education Infant Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Treatment Adherence and Compliance Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marqués de Valdecilla university hospital

Santander, Cantabria, 39008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

Change in the score of theoretical knowledge on pediatric basic life support (BLS) and choking management.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Marqués de Valdecilla

Other

Registry information

Official study title

Effectiveness of an Educational Intervention on Basic Life Support for Caregivers of Infants Under 1 Year: a Crossover Clinical Trial

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 5, 2026
Registry last updated: May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed