이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 4월 30일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (실제)

63

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in the score of theoretical knowledge on pediatric basic life support (BLS) and choking management.
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 11월 20일

기본 완료 (실제)

2026년 3월 1일

연구 완료 (실제)

2026년 3월 20일

연구 등록 날짜

최초 제출

2026년 4월 8일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 30일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다