Airway Obstruction, Foreign-BodyNCT07567638

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

A study testing Explanation of the informational sheet and Theoretical-practical workshop in people with Airway Obstruction, Foreign-Body and Cardiopulmonary Resuscitation, run by Hospital Universitario Marqués de Valdecilla at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Airway Obstruction, Foreign-Body, Cardiopulmonary Resuscitation, Infant
What is being tested?: Explanation of the informational sheet and Theoretical-practical workshop
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteSpain
Study dates: 20 Nov 2025to 20 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Marqués de Valdecilla university hospital
Santander, Cantabria, 39008

Other trials in Spain

About this study

Official title: 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.

Conditions: Airway Obstruction, Foreign-Body, Cardiopulmonary Resuscitation, Infant, Health Education
Being tested: Explanation of the informational sheet, Theoretical-practical workshop
Keywords: Cardiopulmonary Resuscitation/education, Foreign-Body Aspiration/therapy, Padres, Autoeficacia, Patient Education as Topic, Cross-Over Studies
Medical subject headings: Airway Obstruction, Foreign Bodies, Health Education, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Explanation of the informational sheetBehavioural
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 workshopBehavioural
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.

Study groups in NCT07567638
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Explanation of the informational sheet; Behavioral: Theoretical-practical workshop

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Immediately after each intervention and 1 month after the second intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202520 Mar 2026

First posted5 May 2026
Study start20 Nov 2025
Primary completion1 Mar 2026
Study completion20 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Airway Obstruction, Foreign-BodyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
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.
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07567638
Sponsor's protocol ID: 2025.404
Status last verified: Apr 2026
First submitted: 8 Apr 2026
Last updated: 5 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Larrea J. Estadística de atragantamientos en España 2022 - OPRA. 2024
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.
PubMed 847061
Djakow J, Turner NM, Skellett S, Buysse CMP, Cardona F, de Lucas N, Castillo JD, Kiviranta P, Lauridsen KG, Markel F, Martinez-Mejias A, Roggen I, Biarent D; ERC Paediatric Life Support Writing Group collaborators. European Resuscitation Council Guidelines 2025 Paediatric Life Support. Resuscitation. 2025 Oct;215 Suppl 1:110767. doi: 10.1016/j.resuscitation.2025.110767.
PubMed 41117571
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.
PubMed 27771045
Perkins GD, Graesner JT, Semeraro F, Olasveengen T, Soar J, Lott C, Van de Voorde P, Madar J, Zideman D, Mentzelopoulos S, Bossaert L, Greif R, Monsieurs K, Svavarsdottir H, Nolan JP; European Resuscitation Council Guideline Collaborators. European Resuscitation Council Guidelines 2021: Executive summary. Resuscitation. 2021 Apr;161:1-60. doi: 10.1016/j.resuscitation.2021.02.003. Epub 2021 Mar 24.
PubMed 33773824
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.
PubMed 29571750
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.
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.
Mejías AM. Reanimación cardiopulmonar básica y avanzada pediátrica. En: Protocolos diagnósticos y terapéuticos en pediatría. Madrid: Asociación Española de Pediatría; 2020. p. 31-48.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of an Educational Intervention on Basic Life Support for Caregivers of Infants Under 1 Year: a Crossover Clinical Trial
ClinicalTrials.gov ID: NCT07567638
Acronym / sponsor ID: 2025.404
Conditions: Airway Obstruction, Foreign-Body, Cardiopulmonary Resuscitation, Infant, Health Education
Keywords: Cardiopulmonary Resuscitation/education, Foreign-Body Aspiration/therapy, Padres, Autoeficacia, Patient Education as Topic, Cross-Over Studies
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Hospital Universitario Marqués de ValdecillaUniversity, hospital or other
Study start: 20 Nov 2025 (actual)
Primary completion: 1 Mar 2026 (actual)
Study completion: 20 Mar 2026 (actual)
First posted: 5 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Group AB: Explained information sheet + theoretical-practical workshop	Active comparator	Behavioral: Explanation of the informational sheet, Behavioral: Theoretical-practical workshopDelivery 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.
Group BA: theoretical-practical workshop + explanation of informational sheet	Active comparator	Behavioral: Explanation of the informational sheet, Behavioral: Theoretical-practical workshop60-90 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Explanation of the informational sheetIt 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.	Behavioural	Group AB: Explained information sheet + theoretical-practical workshop, Group BA: theoretical-practical workshop + explanation of informational sheet
Theoretical-practical workshopIt 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.	Behavioural	Group AB: Explained information sheet + theoretical-practical workshop, Group BA: theoretical-practical workshop + explanation of informational sheet

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
BackgroundLarrea J. Estadística de atragantamientos en España 2022 - OPRA. 2024
Background: PubMed 847061Bandura 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.
Background: PubMed 41117571Djakow J, Turner NM, Skellett S, Buysse CMP, Cardona F, de Lucas N, Castillo JD, Kiviranta P, Lauridsen KG, Markel F, Martinez-Mejias A, Roggen I, Biarent D; ERC Paediatric Life Support Writing Group collaborators. European Resuscitation Council Guidelines 2025 Paediatric Life Support. Resuscitation. 2025 Oct;215 Suppl 1:110767. doi: 10.1016/j.resuscitation.2025.110767.
Background: PubMed 27771045McCarrison 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.
Background: PubMed 33773824Perkins GD, Graesner JT, Semeraro F, Olasveengen T, Soar J, Lott C, Van de Voorde P, Madar J, Zideman D, Mentzelopoulos S, Bossaert L, Greif R, Monsieurs K, Svavarsdottir H, Nolan JP; European Resuscitation Council Guideline Collaborators. European Resuscitation Council Guidelines 2021: Executive summary. Resuscitation. 2021 Apr;161:1-60. doi: 10.1016/j.resuscitation.2021.02.003. Epub 2021 Mar 24.
Background: PubMed 29571750Tiscar-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.
BackgroundCamejo 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.
BackgroundRamos 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.
BackgroundMejías AM. Reanimación cardiopulmonar básica y avanzada pediátrica. En: Protocolos diagnósticos y terapéuticos en pediatría. Madrid: Asociación Española de Pediatría; 2020. p. 31-48.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567638, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.