Sickle Cell Disease
Conditions
Keywords
Yoga, Behavioral/Social, Pediatrics
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.
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.
Interventions
BEHAVIORALPart 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.
BEHAVIORALPart B Yoga Program
Eight in-person instructor-led group yoga sessions.
Sponsors
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* SCD, any genotype * Presence of chronic pain, the presence of chronic pain will be defined based on the frequency characteristic of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks (ACTTION)-American Pain Society Pain Taxonomy (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Approached That Consent to Participate in Part A | 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. |
| Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B | 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. |
| Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions. | 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. |
| 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. | 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. |
| Number (Proportion) of Participants in Part B Who Complete All Study Assessments Before, and at the End of the Yoga Program. | 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 (Number/Proportion of Participants Who Submit at Least 4 Days of Pain Diary Data Before, and at the End of the Yoga Program) | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment for the trial was between October 2018 and March 2020.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Part A Survey | Protocol Violation | 3 | 3 | 0 |
| Part B Yoga Program | Did not attend intervention | 0 | 0 | 8 |
| Part B Yoga Program | Protocol Violation | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Part A & B Adolescent Patients With SCD and Chronic Pain | Parents of Patients in Part A (Group 2) | Total |
|---|---|---|---|
| Age, Continuous Part A | 16 years | 43.5 years | 18 years |
| Age, Continuous Part B | 17 years | — | 17 years |
| Race (NIH/OMB) Part A American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part A Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part A Black or African American | 12 Participants | 12 Participants | 24 Participants |
| Race (NIH/OMB) Part A More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Part A Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part A Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part A White | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Part B American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B Black or African American | 7 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Part B More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Part B Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part B White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 14 participants | 29 participants |
| Sex: Female, Male Part A Female | 8 Participants | 13 Participants | 21 Participants |
| Sex: Female, Male Part A Male | 7 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Part B Female | 5 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Part B Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 | 0 / 9 |
| other Total, other adverse events | 0 / 15 | 0 / 14 | 0 / 9 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 | 0 / 9 |
Outcome results
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.
Time frame: Through study completion, up to one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Survey Adolescent Patients With SCD and Chronic Pain | 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) | 0 Participants |
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.
Time frame: Enrollment visit
Population: 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.
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.
Time frame: Enrollment visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Survey Adolescent Patients With SCD and Chronic Pain | Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B | 12 Participants |
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.
Time frame: Through study completion, up to one year
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Survey Adolescent Patients With SCD and Chronic Pain | Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions. | 0 Participants |
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.
Time frame: Through study completion, up to one year
Population: Only assessed in participants who were able to attend yoga sessions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Survey Adolescent Patients With SCD and Chronic Pain | 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. | 0 Participants |
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.
Time frame: Through study completion, up to one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Survey Adolescent Patients With SCD and Chronic Pain | Number (Proportion) of Participants in Part B Who Complete All Study Assessments Before, and at the End of the Yoga Program. | 0 Participants |