An interventional study of Explanation of the informational sheet and Theoretical-practical workshop in Airway Obstruction, Foreign-Body, Cardiopulmonary Resuscitation and Infant, sponsored by Hospital Universitario Marqués de Valdecilla. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Hospital Universitario Marqués de Valdecilla · Not applicable, Interventional, and Supportive care
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:
147 studies on the registry are indexed under Airway Obstruction; 25 are open to participants now.
This study's enrollment of 63 is above the median of 53 across 92 interventional studies indexed under Airway Obstruction.
Browse Airway Obstruction studies →Hospital Universitario Marqués de Valdecilla is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
-Previous experience or formal training in pediatric cardiopulmonary resuscitation (accredited courses or undergraduate training)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: Immediately after each intervention and 1 month after the second intervention.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Ran from Nov 2025 to primary completion in Mar 2026, 3 months.
Of 36 non-industry interventional studies with no phase under Airway Obstruction, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 37. This study's 3 months is below that.
Counting every sponsor, half of 44 studies reached it within 16 months; a quarter within 3 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Marqués de Valdecilla