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临床试验/NCT05266833
NCT05266833已完成不适用

Slow-Breathing Curriculum for Stress Reduction in High School Students: A Feasibility Randomized Controlled Trial

Health and Human Performance Foundation2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年1月20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
43
试验地点
2
主要终点
Feasibility - compliance with effectiveness assessments

研究概览

简要总结

The purpose of this study was to test a simple slow breathing curriculum for reducing stress among high school students. The curriculum was developed by the Health and Human Performance Foundation and implemented for this study at a public high school in Colorado, United States.

详细描述

Nearly 1 in 3 US adolescents meet the criteria for anxiety, an issue worsened by the COVID-19 pandemic. Untreated adolescent stress and anxiety can adversely affect teenagers' development, education, and physical and mental health. Although stress-management strategies may seem abundant, many are unscalable or inaccessible for today's youth. Slow diaphragmatic breathing reduces stress and anxiety by downregulating the body's stress response, and is a recommended adolescent stress management strategy. Schools are under pressure to support students in reducing stress, yet diaphragmatic breathing practices are rarely used in school settings. The investigators developed and implemented a 5-week curriculum during COVID-era hybrid learning to conduct the first randomized controlled trial of slow diaphragmatic breathing for stress reduction in a US high school setting.

研究设计

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

入排标准

年龄范围
16 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Students were eligible to participate in this study if they:
  • Were enrolled at study start (baseline period) in one of four senior (12th grade) English classes taught by the teacher who was recruited for the study;
  • Accepted participation in the study, including willingness to abide by the randomization process, by signing student assent on the consent form;
  • Had parental permission to participate in the study, indicated by their signing their consent on the consent form.

排除标准

  • Students were excluded from the study and data collection, but not from class, if they:
  • Chose not to participate; or,
  • Did not receive parental permission.

结局指标

主要结局

Feasibility - compliance with effectiveness assessments

时间窗: 7.5 weeks

Number of participants completing the STAI and CO2TT assessments

Feasibility - effectiveness assessments ease and tolerability

时间窗: 1-week followup period

Ease and tolerability of the preliminary effectiveness assessments was measured as the average ratings on a scale of 0 to 3 (worst to best) of responses about the effectiveness assessments' ease and tolerability.

Feasibility - compliance with breathing curriculum

时间窗: 5 weeks

Number of participants completing the breathing practices

Feasibility - curriculum ease and tolerability

时间窗: 1-week followup period

Ease and tolerability of the breathing curriculum was measured as the average ratings on a scale of 0 to 3 (worst to best) of responses about the curriculum's ease, usefulness, and tolerability.

次要结局

  • Change in in-the-moment stress levels from before to after breathing exercises, as measured by the State-Trait Anxiety Inventory, State (STAI-State) Scale, short version.(5 weeks)
  • Change in general stress levels from before to after the 5-week curriculum, as measured by the State-Trait Anxiety Inventory, Trait (STAI-Trait) Scale.(1.5-week baseline period and 1-week followup period)

研究者

发起方
Health and Human Performance Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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