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

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ClinicalTrials.gov Identifier: NCT03694548
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Nitya Bakshi, Emory University

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 Other: Yoga program: Instructor-led group yoga sessions (Part B) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective single group interventional study (Part B)
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 : November 8, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Yoga program: Instructor-led group yoga sessions (Part B)
Participants enrolled in Part B will receive eight in-person instructor-led group yoga sessions.
Other: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Adherence to submission of pain diary (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.



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694548


Contacts
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Contact: Nitya Bakshi, MBBS, MS 404-727-3149 nitya.bakshi@emory.edu
Contact: Diana Ross, MSN, RN 404-727-9783 diana.ross@emory.edu

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Nitya Bakshi, MBBS, MS       nitya.bakshi@emory.edu   
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30329
Contact: Nitya Bakshi, MD    404-727-3149    nitya.bakshi@emory.edu   
Principal Investigator: Nitya Bakshi, MD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Nitya Bakshi, MBBS, MS Emory University

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Responsible Party: Nitya Bakshi, Assistant Professor of Pediatrics, Emory University
ClinicalTrials.gov Identifier: NCT03694548     History of Changes
Other Study ID Numbers: IRB00102878
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nitya Bakshi, Emory University:
Yoga
Behavioral/Social
Pediatrics
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hematologic Diseases
Genetic Diseases, Inborn
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies