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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2020-03-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Part A Survey

Intervention Type 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 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.

Group Type OTHER

Part A Survey

Intervention Type 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 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.

Group Type EXPERIMENTAL

Part B Yoga Program

Intervention Type BEHAVIORAL

Eight in-person instructor-led group yoga sessions.

Interventions

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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.

Intervention Type BEHAVIORAL

Part B Yoga Program

Eight in-person instructor-led group yoga sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No