Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease
Status: | Recruiting |
---|---|
Conditions: | Anemia |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 12 - 21 |
Updated: | 11/21/2018 |
Start Date: | November 8, 2018 |
End Date: | August 2019 |
Contact: | Nitya Bakshi, MBBS, MS |
Email: | nitya.bakshi@emory.edu |
Phone: | 404-727-3149 |
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.
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.
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.
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.
Inclusion Criteria:
- SCD, any genotype
- Presence of chronic pain, the presence of chronic pain will be defined based on the
frequency characteristic of the 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.
We found this trial at
2
sites
1405 Clifton Road NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Nitya Bakshi, MD
Phone: 404-727-3149
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