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

30 april 2026 uppdaterad av: Ángela Padilla Noriega, Hospital Universitario Marqués de Valdecilla

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

63

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Marques De Valdecilla University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.

Aktiv komparator: 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.

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

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Publikationer och användbara länkar

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Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 november 2025

Primärt slutförande (Faktisk)

1 mars 2026

Avslutad studie (Faktisk)

20 mars 2026

Studieregistreringsdatum

Först inskickad

8 april 2026

Först inskickad som uppfyllde QC-kriterierna

30 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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