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临床试验/NCT06668129
NCT06668129已完成不适用

Effects of a Postural Education Multicomponent Intervention in Primary School Children.

University of the Balearic Islands2 个研究点 分布在 1 个国家目标入组 849 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
849
试验地点
2
主要终点
Knowledge of back health

研究概览

简要总结

The present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (N=1000 children, N=10 schools) and a control group (N=1000 children, N=10 schools). A 9-months intervention program will be implemented. Participants will be evaluated three times: before the intervention (baseline, Month 0), after the intervention (post-test, Month 9) and 6 months after the intervention finished (follow-up, Month 15). The intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) The Back-Care Day at school. The effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. As well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and LBP prevalence in schoolchildren and among teachers involved will be studied. This intervention will provide new insights into the prevention of childhood LBP which may lead to a better management of this health problem throughout an individuals lifetime.

研究设计

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

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school.

排除标准

  • Children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally.

结局指标

主要结局

Knowledge of back health

时间窗: 16 weeks

Validated questionnaire with Spanish children (Cronbach's alpha = 0.82) will be used to ascertain children's' level of knowledge on back care in daily life physical activities. Specifically, this questionnaire has 24 multiple choice items associated with one of the following categories according to conceptual knowledge: topographicalanatomical knowledge (items 1, 2, 3 and 6); functional-anatomical knowledge (items 4, 5 and 7); habits in standing posture (items 8-10); or seated (items 11-13); or lying (items 23 and 24); habits in carrying heavy objects in a backpack (items 14-18); and how to move heavy loads (items 19-22). Additionally, the questionnaire validated with Spanish schoolchildren and used in Méndez et al. will be used to assess back posture knowledge related to general principles of good body mechanics and fear-avoiding beliefs.

次要结局

  • Daily postural habits(16 weeks)
  • Backpack use(16 weeks)
  • LBP prevalence(16 weeks)
  • Back care knowledge(16 weeks)
  • LBP prevalence and daily postural habits(16 weeks)

研究者

发起方
University of the Balearic Islands
申办方类型
Other
责任方
Sponsor

研究点 (2)

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