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临床试验/NCT03752164
NCT03752164已完成不适用

Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events

研究概览

简要总结

This proposed pilot study will examine the tolerability, feasibility, acceptability, and preliminary effects of a gentle yoga intervention "Kids 2 Be & Breathe" (K2B2; a manualized 30 minute gentle yoga and mindfulness session held one-on-one) in urban children aged 7-11 with severe asthma.

详细描述

Pre-Intervention Assessment: permission/assent from the child and consent of the parent/guardian will be obtained and initial data and measurements will be collected to ensure continued eligibility; baseline measures will be assessed.

Intervention: participants will engage in a one-time manualized, age appropriate, 1:1, 30-minute intervention involving gentle yoga and mindfulness techniques in a private room in the Pediatric Research Unit at the Children's Hospital of Richmond. The intervention will be taught by certified and experienced child yoga instructors who have been trained in the study protocol by the applicant. These yoga instructors collaborated with the interdisciplinary research team in the development of manualized age-appropriate yoga sequences. Parents/guardians will be invited to observe the yoga session. Intervention fidelity will be maintained through the use of a manualized intervention and the PI observing all sessions for manual consistency. The intervention will cease if the participant suffers from any asthma symptoms during the intervention, such as wheezing, coughing, retractions, accessory muscle use, chest tightness or shortness of breath, or experiences any other adverse events which precludes the his or her ability to actively participate in the intervention.

Post-Intervention Assessment: upon completion of the intervention, brief semi-structured interviews will be conducted with the child and parent/guardian separately in order to explore the acceptability of the intervention and the PI will again assess the child for any asthma symptoms or adverse events. Post-intervention pulmonary function test and vital sign measurements will then be collected.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • on medium to high doses of steroids and/or leukotriene inhibitors
  • a Child-Asthma Control Test Score <21

排除标准

  • inability to speak English (child); inability to read/write English (parent/guardian)
  • child hospitalized in past two weeks for their asthma
  • current illness associated with oral temperature >100.4
  • pulse ox <95% and/or any wheezing, retractions or accessory muscle use

结局指标

主要结局

Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events

时间窗: 2 hours

whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events

次要结局

  • Preliminary Effects: Change in FEV1(Baseline to 2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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