Division of Pediatric Hematology-Oncology-BMT, Department of Pediatrics, Emory University, Atlanta, GA, USA; Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta, Atlanta, GA, USA.
Division of Hospital Medicine, Department of Pediatrics, Emory University, USA.
Complement Ther Med. 2021 Jun;59:102722. doi: 10.1016/j.ctim.2021.102722. Epub 2021 Apr 21.
To determine the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease.
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).
Eight instructor-led group yoga sessions.
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 h 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.
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.
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.
确定瑜伽治疗镰状细胞病慢性疼痛的可接受性、可行性和安全性。
在这项两部分研究的第一部分中，患有镰状细胞病和慢性疼痛的青少年（第 1 组）及其父母（第 2 组）完成了一项旨在捕捉疼痛特征、与瑜伽相关的态度和实践以及瑜伽项目潜在可接受性的调查。在第二部分中，该研究评估了由指导员带领的团体瑜伽项目的可行性和安全性。该研究已在 clinicaltrials.gov 上注册（NCT03694548）。
8 次指导员带领的团体瑜伽课程。
预先选择了可行性和安全性结果，如下所示：1）同意参加第一部分的镰状细胞病和慢性疼痛青少年患者比例，2）同意参加第一部分的青少年参与者中同意参加第二部分的比例，3）参加第二部分的参与者中至少参加 8 次瑜伽课程的比例，4）参加第二部分的参与者中在每次瑜伽课程结束后 24 小时内因疼痛就诊或住院的比例，5）参加第二部分的参与者中在瑜伽课程结束前和结束时完成所有研究评估的比例，6）疼痛日记提交的依从性。
第一部分中 15 名患者参与者的中位数年龄为 16 岁（IQR 14-17），14 名父母的中位数年龄为 43.5 岁（IQR 42-51）。大多数参与者为女性。大多数参与者的反应表明对瑜伽的看法较为积极。来自第一部分的 9 名青少年中有 6 名（60%）参加了研究的第二部分。第二部分中 9 名参与者的中位数年龄为 17 岁（IQR 15-18），其中 5 名为女性（53.3%）。只有 1 名参与者能够参加提供的 8 次瑜伽课程中的 3 次，并且在瑜伽课程后没有出现急诊就诊或住院治疗的情况。本研究中没有达到其他可行性终点。
患有镰状细胞病和慢性疼痛的患者总体上对瑜伽持积极态度，但在瑜伽临床试验的招募和保留参与者方面存在挑战，并且在面对面团体瑜伽干预的可行性方面存在障碍。
