Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Emory University
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Approached That Consent to Participate in Part A
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Part A Survey: Group 1 Adolescent Patients with SCD
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.
Intervention: Part A Survey (Behavioral)
Part A Survey: Group 2 Parents of Adolescent Patients with SCD in Part A
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.
Intervention: Part A Survey (Behavioral)
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.
Intervention: Part B Yoga Program (Behavioral)
Outcomes
Primary Outcomes
Number (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.
Number (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.
Number (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.
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.
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.
Number (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 (Number/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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nitya Bakshi
Assistant Professor of Pediatrics
Emory University