Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease
Sponsor:
Emory University
Collaborators:
Information provided by (Responsible Party):
Nitya Bakshi，Emory University
| Tracking Information | |||
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| First Submitted Date ICMJE | September 25, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | October 2018 | ||
| Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures 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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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease |
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| Official Title ICMJE | Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease |
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| Brief Summary | 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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| Detailed Description | 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Intervention Model: Single Group Assignment Intervention Model Description: Prospective single group interventional study (Part B) Masking: Interventional Masking Description: Primary Purpose: Supportive Care |
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| Intervention ICMJE |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
20 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | August 2019 | ||
| Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria 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. | ||
| Sex/Gender |
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| Ages | 12 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Nitya Bakshi，Emory University | ||
| Study Sponsor ICMJE | Emory University | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Emory University | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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