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Study terminated due to COVID-19 pandemic.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Survey: Group 1 Adolescent Patients with SCD | Other | Adolescent patients with SCD and chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. |
|
| Part A Survey: Group 2 Parents of Adolescent Patients with SCD in Part A | Other | Parents of adolescent patients with SCD and chronic pain from Group 1 completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. |
|
| Part B Yoga Program | Experimental | Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part A Survey | Behavioral | Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. |
| Measure | Description | Time Frame |
|---|---|---|
| Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Approached That Consent to Participate in Part A | 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. | Enrollment visit |
| Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B | 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. | Enrollment visit |
| Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions. | 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. | Through study completion, up to one year |
| Number (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. | 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. | Through study completion, up to one year |
| Number (Proportion) of Participants in Part B Who Complete All Study Assessments Before, and at the End of the Yoga Program. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nitya Bakshi, MBBS, MS | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Children's Healthcare of Atlanta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33892094 | Result | Bakshi N, Cooley A, Ross D, Hawkins L, Sullivan M, Astles R, Sinha C, Katoch D, Peddineni M, Gee BE, Lane PA, Krishnamurti L. A pilot study of the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease. Complement Ther Med. 2021 Jun;59:102722. doi: 10.1016/j.ctim.2021.102722. Epub 2021 Apr 21. |
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In Part A of this two-part study, adolescents with SCD and chronic pain (Group 1) and their parent (Group 2) completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. In Part B, the study assessed the feasibility and safety of an instructor-led group yoga program.
Recruitment for the trial was between October 2018 and March 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Survey Adolescent Patients With SCD and Chronic Pain (Group 1) | Adolescent patients with Sickle Cell Disease (SCD) and chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. |
| FG001 | Part A Survey Parents of Patients in Part A (Group 2) | Parents of adolescent patients with SCD and chronic pain from Group 1 completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD. |
| FG002 | Part B Yoga Program | Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions. Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A Survey |
|
| ||||||||||||||||||
| Part B Yoga Program |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A & B Adolescent Patients With SCD and Chronic Pain | Part A: Adolescent patients with sickle cell disease (SCD) and chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program. Part B: Part A adolescent patients with SCD then had the opportunity to enroll in Part B yoga program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Parents were not enrolled in Part B. 12 participants started Part B, but only 9 participants are included as the number analyzed because 3 subjects were withdrawn due to protocol violation and not analyzable. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Approached That Consent to Participate in Part A | 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. | Unable to assess outcome: As eligibility for Part A was determined based on patient response regarding presence of chronic pain, and if patients were not interested when approached to determine eligibility or potential interest in the study, we were not always able to assess if they would have met eligibility criteria. Thus, we were not able to accurately estimate the proportion of individuals with SCD and chronic pain who agreed to participate in Part A. | Posted | Enrollment visit |
|
Through study completion, up to one year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Group 1: Adolescent SCD Patients Survey | Adolescent Sickle Cell Disease (SCD) Patients with chronic pain completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program. Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program. |
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See published manuscript
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nitya Bakshi | Emory University | 404-727-3149 | nitya.bakshi@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2018 | Jun 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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Part A: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of yoga program in adolescent patients with SCD and chronic pain and their parents
Part B: Feasibility and safety of yoga program in adolescent patients with SCD and chronic pain from Part A
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| Part B Yoga Program | Behavioral | Eight in-person instructor-led group yoga sessions. |
|
| Through study completion, up to one year |
| Adherence to Submission of Pain Diary (Number/Proportion of Participants Who Submit at Least 4 Days of Pain Diary Data Before, and at the End of the Yoga Program) | 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. | Through study completion, up to one year |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| NOT COMPLETED |
|
|
| BG001 | Parents of Patients in Part A (Group 2) | Parents of patients in Part A completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Parents were not enrolled in Part B. 12 participants started Part B, but only 9 participants are included as the number analyzed because 3 subjects were withdrawn due to protocol violation and not analyzable. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Parents were not enrolled in Part B. 12 participants started Part B, but only 9 participants are included as the number analyzed because 3 subjects were withdrawn due to protocol violation and not analyzable. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B | 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. | Posted | Count of Participants | Participants | Enrollment visit |
|
|
|
| Primary | Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions. | 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. | 12 participants started Part B, but only 9 participants are included as the number analyzed because 3 subjects were withdrawn due to protocol violation and not analyzable. | Posted | Count of Participants | Participants | Through study completion, up to one year |
|
|
|
| Primary | Number (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. | 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. | Only assessed in participants who were able to attend yoga sessions. | Posted | Count of Participants | Participants | Through study completion, up to one year |
|
|
|
| Primary | Number (Proportion) of Participants in Part B Who Complete All Study Assessments Before, and at the End of the Yoga Program. | 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. | Posted | Count of Participants | Participants | Through study completion, up to one year |
|
|
|
| Primary | Adherence to Submission of Pain Diary (Number/Proportion of Participants Who Submit at Least 4 Days of Pain Diary Data Before, and at the End of the Yoga Program) | 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. | Posted | Count of Participants | Participants | Through study completion, up to one year |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Part A Group 2: Parents of Adolescent SCD Patients Survey | Parents of adolescent SCD Patients with chronic pain from Group 1 completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program. Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Part B Adolescent SCD Patients Yoga Program | Participants from Part A Group 1 had the opportunity to enroll in Part B to receive eight in-person instructor-led group yoga sessions. Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|