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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07567638
Enrollment
63
Registered
2026-05-05
Start date
2025-11-20
Completion date
2026-03-20
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALExplanation of the informational sheet

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.

BEHAVIORALTheoretical-practical workshop

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.

Sponsors

Hospital Universitario Marqués de Valdecilla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026