A Pilot Study of the Acceptability, Feasibility and Safety of Yoga for Chronic Pain in Sickle Cell Disease.

Abstract Objectives To determine the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease. Design and Setting 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. In Part B, the study assessed the feasibility and safety of an instructor-led group yoga program. The study was registered on clinicaltrials.gov (NCT03694548). Intervention Eight instructor-led group yoga sessions Main Outcome Measures Feasibility and safety outcomes were chosen a priori, as follows: 1) Proportion of adolescent patients with SCD and chronic pain approached that consent to participate in Part A, 2) Proportion of adolescent participants enrolled in Part A that consent to participate in Part B, 3) Proportion of participants enrolled in Part B that attend at least 6 of 8 yoga sessions, 4) Proportion of participants enrolled in Part B with an ED visit or a hospitalization for pain within 24 hours of completion of each yoga session, 5) Proportion of participants in Part B who complete all study assessments before, and at the end of the yoga program, 6) Adherence to submission of pain diary. Results The median age of 15 patient participants in Part A was 16 (IQR 14-17), and 14 parents was 43.5 (IQR 42-51). Most participants were female. Most participant responses indicated a positive opinion of yoga. Nine adolescents (60%) from Part A participated in Part B of the study. The median age of 9 participants in Part B was 17 (IQR 15-18), and 5 of the 9 participants were female (53.3%). Only one participant was able to attend 3 of the 8 yoga sessions offered, and did not experience any ED visits or hospitalizations following the yoga sessions. None of the other feasibility endpoints were met in this study. Conclusions Patients with SCD and chronic pain overall have a positive opinion of yoga, but there are challenges with recruitment and retention of participants in a clinical trial of yoga, and barriers to feasibility of an in-person group yoga intervention.