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临床试验/NCT01180842
NCT01180842已完成2 期

Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With CF

Children's Hospitals and Clinics of Minnesota2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Improve Quality of Life measured through self report questionnaires

研究概览

简要总结

The investigators research question is whether or not yoga effectively alleviates symptoms of pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga does prove to be effective, the investigators will educate our CF population about the benefits they may experience if they choose to incorporate yoga into their CF therapy. The investigators will also go on to do further research of other complementary alternative medicine therapies.

This is a pre/post-test study with 20 subjects. The subjects will serve as their own controls. Each subject will participate in six yoga sessions over a ten week period. Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is affected by stress. Testing of cortisol throughout the study will help us determine the subjects' stress level throughout the study.

详细描述

H1: The implementation of a yoga therapy program decreases symptoms of pain within our CF population.

H2: The implementation of a yoga therapy program decreases symptoms of sleep disturbance within our CF population.

H3: The implementation of a yoga therapy program decreases symptoms of anxiety within our CF population.

H4: The implementation of a yoga therapy program decreases symptoms of depression within our CF population.

研究设计

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

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Positive diagnosis of CF
  • Males or females within the ages of 9 and 18

排除标准

  • No positive diagnosis of CF
  • Younger than 9 years of age or older than 18 years of age
  • Concomitant illness or disease that may inhibit the patient's ability to participate in the study as determined by the principal investigator
  • The patient has participated in an investigational treatment study 30 days prior to pre-session week -
  • The patient is currently participating in yoga sessions one or more times per week.

结局指标

主要结局

Improve Quality of Life measured through self report questionnaires

时间窗: We expect this study to last one year.

Tool: CFQ-R

次要结局

  • Reduce symptoms of sleep disturbance measured through self report questionnaires(1 year)
  • Reduce symptoms of pain measured through self report questionnaires(1 year)
  • Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing(1 year)
  • Reduce symptoms of depression measured through self report questionnaires and cortisol testing(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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