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临床试验/NCT07567638
NCT07567638已完成不适用

Effectiveness of an Educational Intervention on Basic Life Support for Caregivers of Infants Under 1 Year: a Crossover Clinical Trial

Hospital Universitario Marqués de Valdecilla1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究者

发起方
Hospital Universitario Marqués de Valdecilla
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ángela Padilla Noriega

Pediatric nursing resident

Hospital Universitario Marqués de Valdecilla

研究点 (1)

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