Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease

NCT03694548 | Terminated Results

• 1 other identifier: IRB00102878
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease

Keywords

Yoga; Behavioral/Social; Pediatrics

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Study Arms (3)

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.

Behavioral: Part A Survey

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.

Behavioral: Part A Survey

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.

Behavioral: Part B Yoga Program

Interventions

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.

Part A Survey: Group 1 Adolescent Patients with SCD; Part A Survey: Group 2 Parents of Adolescent Patients with SCD in Part A

Part B Yoga Program BEHAVIORAL

Eight in-person instructor-led group yoga sessions.

Part B Yoga Program

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• 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.

  PMID: 33892094 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell; Behavior

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

See published manuscript

Results Point of Contact

• Title: Dr. Nitya Bakshi
• Organization: Emory University

nitya.bakshi@emory.edu

404-727-3149

Study Officials

• Nitya Bakshi, MBBS, MS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: 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

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 3, 2018
• Study Start: November 8, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: July 16, 2021
• Results First Posted: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)