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

• Sponsor: Emory University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03694548
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Arms: 3
• Actual Duration (Months): 16
• Patients Per Site: 17.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease	Behavioral: Part A Survey; Behavioral: Part B Yoga Program	N/A

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.

This study will be conducted in 2 parts, Part A and Part B:

Part A will assess attitudes and practices related to yoga and potential acceptability of a yoga program in adolescents with SCD and chronic pain (Group 1), and their parents/guardians (Group 2). Up to 40 adolescents who meet inclusion criteria, and do not meet exclusion criteria, and their parent/guardian will be enrolled on Part A until 20 adolescents are enrolled on Part B. Only one parent/guardian per adolescent participant will be enrolled.

Part B will assess the feasibility and safety of a yoga program for SCD and chronic pain. This program will comprise of 8 instructor-led group yoga sessions. The study will measure psychological factors implicated in chronic pain, and pain-related patient-reported outcomes, and assess the feasibility of collection of these outcomes. The study will also explore patient acceptability of yoga through qualitative interviews and conduct a needs assessment for the development of a smartphone app for yoga. Up to 20 adolescents who meet inclusion criteria, and do not meet exclusion criteria will be enrolled in Part B.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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 APart 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
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease
• Actual Study Start Date: Nov 8, 2018
• Actual Primary Completion Date: Mar 9, 2020
• Actual Study Completion Date: Mar 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Behavioral: 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.
Other: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: Part B Yoga Program; Eight in-person instructor-led group yoga sessions.

Outcome Measures

Primary Outcome Measures

1. Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Approached That Consent to Participate in Part A [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.

2. Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B [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.

3. Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions. [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.

4. 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. [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.

5. Number (Proportion) of Participants in Part B Who Complete All Study Assessments Before, and at the End of the Yoga Program. [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.

6. 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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 21 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30329

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Nitya Bakshi, MBBS, MS, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 13, 2018

More Information

Publications

None provided.

• Responsible Party: Nitya Bakshi, Assistant Professor of Pediatrics, Emory University
• ClinicalTrials.gov Identifier: NCT03694548
• Other Study ID Numbers: IRB00102878
• First Posted: Oct 3, 2018
• Last Update Posted: Jul 16, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nitya Bakshi, Assistant Professor of Pediatrics, Emory University: Yoga; Behavioral/Social; Pediatrics
• Additional relevant MeSH terms: Anemia, Sickle Cell; Chronic Pain

Study Results

Participant Flow

Recruitment Details	Recruitment for the trial was between October 2018 and March 2020.
Pre-assignment Detail	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.

Arm/Group Title	Part A Survey Adolescent Patients With SCD and Chronic Pain (Group 1)	Part A Survey Parents of Patients in Part A (Group 2)	Part B Yoga Program
Arm/Group Description	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.	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.	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.
Period Title: Part A Survey
STARTED	18	17	0
COMPLETED	15	14	0
NOT COMPLETED	3	3	0
Period Title: Part A Survey
STARTED	0	0	12
COMPLETED	0	0	1
NOT COMPLETED	0	0	11

Baseline Characteristics

Arm/Group Title	Part A & B Adolescent Patients With SCD and Chronic Pain	Parents of Patients in Part A (Group 2)	Total
Arm/Group Description	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 completed a survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program.	Total of all reporting groups
Overall Participants	15	14	29
Age (years) [Median (Inter-Quartile Range) ]
Part A	16	43.5	18
Part B	17	17
Sex: Female, Male (Count of Participants)
Female	8 53.3%	13 92.9%	21 72.4%
Male	7 46.7%	1 7.1%	8 27.6%
Female	5 33.3%	0 0%	5 17.2%
Male	4 26.7%	0 0%	4 13.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	12 80%	12 85.7%	24 82.8%
White	0 0%	1 7.1%	1 3.4%
More than one race	3 20%	1 7.1%	4 13.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 46.7%	0 0%	7 24.1%
White	0 0%	0 0%	0 0%
More than one race	2 13.3%	0 0%	2 6.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	14 100%	29 100%

Outcome Measures

1. Primary Outcome

Title	Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Approached That Consent to Participate in Part A
Description	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.
Time Frame	Enrollment visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part A Survey Adolescent Patients With SCD and Chronic Pain
Arm/Group Description	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.
Measure Participants	0

2. Primary Outcome

Title	Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B
Description	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.
Time Frame	Enrollment visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A Survey Adolescent Patients With SCD and Chronic Pain
Arm/Group Description	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. 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.
Measure Participants	18
Count of Participants [Participants]	12 80%

3. Primary Outcome

Title	Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions.
Description	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.
Time Frame	Through study completion, up to one year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part B Yoga Program
Arm/Group Description	Participants enrolled in Part B will receive eight in-person instructor-led group yoga sessions. Yoga program: Instructor-led group yoga sessions (Part B): Participants enrolled in Part B will receive eight in-person instructor-led group yoga sessions. Proposed yoga session will comprise of poses, breathing exercises, and guided relaxation.
Measure Participants	9
Count of Participants [Participants]	0 0%

4. Primary Outcome

Title	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.
Description	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.
Time Frame	Through study completion, up to one year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B Yoga Program
Arm/Group Description	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.
Measure Participants	1
Count of Participants [Participants]	0 0%

5. Primary Outcome

Title	Number (Proportion) of Participants in Part B Who Complete All Study Assessments Before, and at the End of the Yoga Program.
Description	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.
Time Frame	Through study completion, up to one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part B Yoga Program
Arm/Group Description	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.
Measure Participants	1
Count of Participants [Participants]	0 0%

6. Primary Outcome

Title	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)
Description	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.
Time Frame	Through study completion, up to one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part B Yoga Program
Arm/Group Description	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.
Measure Participants	1
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	Through study completion, up to one year.
Arm/Group Title	Part A Group 1: Adolescent SCD Patients Survey		Part A Group 2: Parents of Adolescent SCD Patients Survey		Part B Adolescent SCD Patients Yoga Program
Arm/Group Description	Adolescent Sickle Cell Disease (SCD) Patients with 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.		Parents of adolescent SCD Patients with 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. Part A Survey: Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a 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.
All Cause Mortality
	Part A Group 1: Adolescent SCD Patients Survey		Part A Group 2: Parents of Adolescent SCD Patients Survey		Part B Adolescent SCD Patients Yoga Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/14 (0%)		0/9 (0%)
Serious Adverse Events
	Part A Group 1: Adolescent SCD Patients Survey		Part A Group 2: Parents of Adolescent SCD Patients Survey		Part B Adolescent SCD Patients Yoga Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/14 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Part A Group 1: Adolescent SCD Patients Survey		Part A Group 2: Parents of Adolescent SCD Patients Survey		Part B Adolescent SCD Patients Yoga Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/14 (0%)		0/9 (0%)

Limitations/Caveats

See published manuscript

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.