Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease
赞助:
Emory University
合作者:
信息的提供 (责任方):
Nitya Bakshi，Emory University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 25, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | August 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Proportion of adolescent patients with SCD and chronic pain approached that consent to participate in Part A.[ Time Frame: Enrollment visit ] The study hypothesis that the proportion of adolescent patients with SCD and chronic pain approached that consent to complete a survey to assess attitudes and practices related to yoga (Part A) will be 50% or greater. Proportion of adolescent patients with SCD and chronic pain enrolled in Part A that consent to participate in Part B.[ Time Frame: Enrollment visit ] The study hypothesis is that the proportion of adolescent patients with SCD and chronic pain enrolled in Part A that consent to participate in Part B will be 50% or greater. Proportion of participants enrolled in Part B that attend at least 6 of 8 yoga sessions.[ Time Frame: Through study completion, up to one year ] The study hypothesis is that the proportion of participants enrolled in Part B that attend at least 6 of 8 in-person yoga sessions will be 80% or greater. Proportion of participants enrolled in Part B with an Emergency Department visit or a hospitalization for pain within 24 hours of completion of each yoga session.[ Time Frame: Through study completion, up to one year ] The study hypothesis is that the proportion of participants enrolled in Part B with an Emergency Department visit or a hospitalization for pain within 24 hours of completion of each yoga session will be 30% or less. Proportion of participants in Part B who complete all study assessments before, and at the end of the yoga program.[ Time Frame: Through study completion, up to one year ] The study hypothesis is that the proportion of participants who complete all study assessments before, and at the end of the yoga program will be 70% or greater. Adherence to submission of pain diary (Proportion of participants who submit at least 4 days of pain diary data before, and at the end of the yoga program)[ Time Frame: Through study completion, up to one year ] The study hypothesis is that the proportion of participants who submit at least 4 days of pain diary data before, and at the end of the yoga program will be 70% or greater. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease | ||
| 正式标题 ICMJE | Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease | ||
| 简要概况 | Chronic Pain is associated with morbidity and poor quality of life in patients with Sickle Cell Disease (SCD). Complementary therapies, such as yoga are beneficial in patients with non-SCD chronic pain conditions. Yoga was shown to be acceptable, feasible and helpful in one study in acute SCD pain. The purpose of the study is to assess the acceptability, feasibility, and safety of yoga for chronic pain in SCD. |
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| 详细说明 | Pain is a major cause of morbidity, impaired quality of life, and healthcare utilization in SCD. Yoga is beneficial in patients with non-SCD chronic pain conditions. Yoga was shown to be acceptable, feasible and helpful in one study in acute SCD pain, but there are currently no data on yoga for chronic pain in SCD. This study has the following aims: In Aim 1, the study will assess the acceptability of yoga for chronic pain in SCD. The study will also assess the feasibility and safety of a yoga program for adolescents with SCD and chronic pain. In Aim 2, the study will study the feasibility of collection of psychological and patient-reported outcomes in a study of yoga for chronic pain in SCD. In Aim 3, the study will explore patient acceptability of yoga and conduct a needs assessment for the development of a smartphone app for yoga through qualitative interviews. This study will be conducted in 2 parts, Part A and Part B: Part A will assess attitudes and practices related to yoga and potential acceptability of a yoga program in adolescents with SCD and chronic pain (Group 1), and their parents/guardians (Group 2). Up to 40 adolescents who meet inclusion criteria, and do not meet exclusion criteria, and their parent/guardian will be enrolled on Part A until 20 adolescents are enrolled on Part B. Only one parent/guardian per adolescent participant will be enrolled. Part B will assess the feasibility and safety of a yoga program for SCD and chronic pain. This program will comprise of 8 instructor-led group yoga sessions. The study will measure psychological factors implicated in chronic pain, and pain-related patient-reported outcomes, and assess the feasibility of collection of these outcomes. The study will also explore patient acceptability of yoga through qualitative interviews and conduct a needs assessment for the development of a smartphone app for yoga. Up to 20 adolescents who meet inclusion criteria, and do not meet exclusion criteria will be enrolled in Part B. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: Prospective single group interventional study (Part B) 盲法: Interventional 盲法描述: 主要目的: Supportive Care |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
20 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 2019 | ||
| 预计主要完成日期 | August 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - SCD, any genotype - Presence of chronic pain, the presence of chronic pain will be defined based on the frequency characteristic of the AAPT criteria for chronic SCD pain, as the presence of SCD-related pain on 15 or more days of the month, for the past 6 months. - Age 12 -21 at time of enrollment - English speaking Exclusion Criteria: - Daytime or nighttime oxygen requirement for hypoxia - Most Recent hemoglobin< 5 or platelet count < 20 - Known Pregnancy - Severe cognitive issues not allowing for understanding consent/assent and instructions - History of overt stroke with significant residual motor weakness - History of recurrent syncope - Any other comorbidities or health concerns that the treating healthcare provider or investigators feel are a contra-indication for participation in the study. | ||
| 性别 |
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| 年龄 | 最小年龄：12 Years ，最大年龄：21 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Nitya Bakshi，Emory University | ||
| 研究赞助商 ICMJE | Emory University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Emory University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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