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

July 9, 2021 updated by: Nitya Bakshi, Emory University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Approached That Consent to Participate in Part A
Time Frame: 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.
Enrollment visit
Number (Proportion) of Adolescent Patients With SCD and Chronic Pain Enrolled in Part A That Consent to Participate in Part B
Time Frame: 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.
Enrollment visit
Number (Proportion) of Participants Enrolled in Part B That Attend at Least 6 of 8 Yoga Sessions.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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)
Time Frame: 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.
Through study completion, up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2018

Primary Completion (ACTUAL)

March 9, 2020

Study Completion (ACTUAL)

March 9, 2020

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (ACTUAL)

October 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00102878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sickle Cell Disease

Clinical Trials on Part A Survey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe