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临床试验/NCT03796754
NCT03796754已完成不适用

Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)

研究概览

简要总结

The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.

研究设计

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

入排标准

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

入选标准

  • •Students from participating primary schools in Berlin aged 6-12 years
  • •Written declaration of consent of the parent or legal guardian

排除标准

  • •Serious chronic or acute diseases
  • •Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
  • •Participation in another study

研究组 & 干预措施

YoBEKA Intervention

Active Comparator

干预措施: YoBEKA (Behavioral)

Control group

No Intervention

结局指标

主要结局

Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)

时间窗: Change baseline, 4 months

Filled out by students, assessing composite score (range 29-94): subscale 1 (stress-vulnerability \[range 7-28\]) summed with subscale 3 (stress symptoms and well-being \[range 22-66\]), lower score meaning a better outcome

次要结局

  • Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)(Change Baseline, 4 months, 12 months)
  • Perceived Stress Scale (PSS)(Change Baseline, 4 months, 12 months)
  • Teacher anxiety and stress inventory (LASI)(Change Baseline, 4 months, 12 months)
  • Screening for somatoform disorders of childhood and adolescence (SOMS-E)(Change Baseline, 4 months, 12 months)
  • Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)(Change Baseline, 4 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Michalsen

Principal Investigator

Charite University, Berlin, Germany

研究点 (1)

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