Trial Outcomes & Findings for Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease (NCT NCT03694548)

Last Updated: 2021-07-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Enrollment visit

Results posted on

2021-07-16

Participant Flow

Recruitment for the trial was between October 2018 and March 2020.

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.

Participant milestones

Participant milestones
Measure	Part A Survey Adolescent Patients With SCD and Chronic Pain (Group 1) 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 for chronic pain in SCD. Part 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.	Part A Survey Parents of Patients in Part A (Group 2) 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. Part 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.	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. Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions.
Part A Survey STARTED	18	17	0
Part A Survey COMPLETED	15	14	0
Part A Survey NOT COMPLETED	3	3	0
Part B Yoga Program STARTED	0	0	12
Part B Yoga Program COMPLETED	0	0	1
Part B Yoga Program NOT COMPLETED	0	0	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A Survey Adolescent Patients With SCD and Chronic Pain (Group 1) 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 for chronic pain in SCD. Part 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.	Part A Survey Parents of Patients in Part A (Group 2) 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. Part 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.	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. Part B Yoga Sessions: Eight in-person instructor-led group yoga sessions.
Part A Survey Protocol Violation	3	3	0
Part B Yoga Program Protocol Violation	0	0	3
Part B Yoga Program Did not attend intervention	0	0	8

Baseline Characteristics

Parents were not enrolled in Part B. 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.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Part A Survey Adolescent Patients With SCD and Chronic Pain n=18 Participants 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 A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.
Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B	12 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A Survey Adolescent Patients With SCD and Chronic Pain n=9 Participants 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 A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.
Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions.	0 Participants

PRIMARY outcome

Timeframe: Through study completion, up to one year

Population: Only assessed in participants who were able to attend yoga sessions.

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.

Outcome measures

Outcome measures
Measure	Part A Survey Adolescent Patients With SCD and Chronic Pain n=1 Participants 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 A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Part A Survey Adolescent Patients With SCD and Chronic Pain n=1 Participants 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 A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.
Number (Proportion) of Participants in Part B Who Complete All Study Assessments Before, and at the End of the Yoga Program.	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Part A Survey Adolescent Patients With SCD and Chronic Pain n=1 Participants 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 A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.
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

Adverse Events

Part A Group 1: Adolescent SCD Patients Survey

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part A Group 2: Parents of Adolescent SCD Patients Survey

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B Adolescent SCD Patients Yoga Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nitya Bakshi

Emory University

Phone: 404-727-3149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Part A & B Adolescent Patients With SCD and Chronic Pain n=15 Participants 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.	Parents of Patients in Part A (Group 2) n=14 Participants 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.	Total n=29 Participants Total of all reporting groups
Age, Continuous Part A	16 years n=15 Participants • Parents were not enrolled in Part B. 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.	43.5 years n=14 Participants • Parents were not enrolled in Part B. 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.	18 years n=29 Participants • Parents were not enrolled in Part B. 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.
Age, Continuous Part B	17 years n=9 Participants • Parents were not enrolled in Part B. 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.	—	17 years n=9 Participants • Parents were not enrolled in Part B. 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.
Sex: Female, Male Part A · Female	8 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	13 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	21 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Sex: Female, Male Part A · Male	7 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	1 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	8 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Sex: Female, Male Part B · Female	5 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	5 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Sex: Female, Male Part B · Male	4 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	4 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part A · American Indian or Alaska Native	0 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part A · Asian	0 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part A · Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part A · Black or African American	12 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	12 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	24 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part A · White	0 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	1 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	1 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part A · More than one race	3 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	1 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	4 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part A · Unknown or Not Reported	0 Participants n=15 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=14 Participants • Parents were not enrolled in Part B. 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.	0 Participants n=29 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part B · American Indian or Alaska Native	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part B · Asian	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part B · Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part B · Black or African American	7 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	7 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part B · White	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part B · More than one race	2 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	2 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Race (NIH/OMB) Part B · Unknown or Not Reported	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.	0 Participants Parents were not enrolled in Part B. 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.	0 Participants n=9 Participants • Parents were not enrolled in Part B. 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.
Region of Enrollment United States	15 participants n=15 Participants	14 participants n=14 Participants	29 participants n=29 Participants