跳至主要内容
临床试验/NCT04914871
NCT04914871Unknown不适用

Readiness for Basic Life Support in Schools: Randomized Controlled Trial

Universidad Nacional de Colombia0 个研究点目标入组 70 人开始时间: 2021年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
主要终点
Viability

研究概览

简要总结

This research is a response to problems with Cardiovascular Disease in Colombia, where circulatory system diseases are the first cause of mortality in the adult population, making them a critical issue for the country. It is known that around 70% of cardiac arrests occur outside health institutions, generally at home or on public roads.

To reduce these high mortality rates, international recommendations were issued to establish strategies to train the general population in cardiopulmonary resuscitation, especially school-age children. This constitutes a key stage for initiating learning. This condition significantly favors learning and preserving the acquired knowledge for the rest of their life.

Based on the reasons above, this pilot project seeks to be the first approach at the national level to train second-grade elementary school children in Basic Life Support. This training will describing the step by step experiences of the participants, focusing on: project viability related to recruitment and follow-up, acceptability, the experience of participation from the educational community, and the effects of implementing the intervention on the knowledge and skills in the child population. A virtual protocol will be implemented (adapted to the current situation generated by the Coronavirus pandemic), and will be developed through didactic methodologies in three 60-minute educational sessions, during regular class hours.

详细描述

  1. Research question What are the viability, acceptability, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention in two schools in the city of Tunja in 2021?
  2. General objective:

To describe the viability, acceptability, participation experience, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention, in two schools in the city of Tunja in 2021. 3. Specific objectives To carry out the characterization of the child population under study. To describe the viability of the UN Lifeguard Kids in the Tunja version intervention in terms of recruitment and follow through.

To describe the acceptability of the UN Lifeguard Kids in the Tunja version intervention for the child population that receives it.

To describe the experience of participating in the UN Lifeguard Kids in the Tunja version intervention for the academic community.

To describe the effects of the UN Lifeguard Kids in the Tunja version intervention on theoretical knowledge and practical skills in the child population that receives it. 4. A sample population of 70 children was determined as appropriate for the study. Two second-graded classes were selected to fulfill this requirement. Children were assigned to a control or test group using simple random sampling. Finally, five additional children were added to reduce sample attrition. 5. Biases control

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The research will be conducted using the double-blinded model since the children, parents, and research assistants who will carry out the pre- and post-test measurements, will not know the assignment of the groups, control, and intervention.

入排标准

年龄范围
7 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Seven and eight-year-old.
  • •Children who are in the second grade of elementary school in two schools in the city of Tunja.
  • •Children's families with an available computer tablet or mobile device and internet connection will be considered for the study.
  • •Children who have a caregiver 18 years of age or older to accompany them during the intervention.
  • •Children with adequate learning skills (This data will be obtained from the report of the course teacher)

排除标准

  • •Children who have received a scientific intervention on CPR.
  • •Children who participate in a rescue force (i.e., police, civil defense, brigade members).
  • •Children with a diagnosis of physical or mental disability (autism spectrum disorder, trisomy 21, Asperger syndrome, Tourette syndrome, attention deficit hyperactivity disorder (ADHD), severe visual, hearing, or motor problems, and/or similar disabilities).

研究组 & 干预措施

The experimental protocol UN Lifeguard Kids in the Tunja version

Experimental

Group to which the experimental protocol will be offered.

干预措施: Protocol UN Lifeguard Kids in the Tunja version (Behavioral)

Educational session, accident prevention and wound management.

Placebo Comparator

The control group will be offered the Educational session.

干预措施: Educational session accident prevention and wound management (Behavioral)

结局指标

主要结局

Viability

时间窗: 8 weeks

This variable is defined as the proportion of eligible participants who agree to participate in the study. Selection and monitoring form: In the first place, the form is filled out to discern if the children meet the inclusion criteria, then the consent form is signed, and finally the children agree to participate in the study. Then, the children who enter training sessions complete a form, in order to measure the percentage of children who attended all the sessions and to compare it with the children who were initially recruited.

Acceptability

时间窗: 8 weeks

Defined as the degree to which the participants were comfortable with their experience with the nursing intervention "UN Salvavidas Kids Tunja version". Participant's satisfaction questionnaire with the intervention: This approach has two parts, the first one involves three open questions and the second 6 with closed answers using dichotomous nominal variables.

次要结局

  • Skills in Basic Life Support.(8 weeks)
  • knowledge in Basic Life Support.(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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