Purpose of this Study
We are doing this study to compare different approaches to pain relief for people with sickle cell disease (SCD). We want to find if acupuncture or guided relaxation therapies are helpful methods to lower pain from SCD, and we also want to find out which options work best for most people.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with SCD
- Are able to speak and understand English
- Have had pain for some days, most days, or every day for the past 3 months
- Currently have pain that is at least 3 on a scale from 0-10
For more information about who can join this study, contact the study team at olivia.fernandez@duke.edu.
- Are diagnosed with SCD
- Are able to speak and understand English
- Have had pain for some days, most days, or every day for the past 3 months
- Currently have pain that is at least 3 on a scale from 0-10
For more information about who can join this study, contact the study team at olivia.fernandez@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you join in this study, you will:
- Get a random assignment (fair, equal chance) to 1 of 3 study groups:
-- Acupuncture: you will have acupuncture sessions twice a week for 5 weeks (10 visits total); OR
-- Guided relaxation: you will watch instructional videos every day for 6 weeks; OR
-- Usual care: you will continue doing what you are doing for pain relief
After 6 weeks, we might ask you to continue with the pain relief approach in your assigned group or we might ask you to switch to a different approach. Your participation in the study will last for up to 24 weeks.
- Get a random assignment (fair, equal chance) to 1 of 3 study groups:
-- Acupuncture: you will have acupuncture sessions twice a week for 5 weeks (10 visits total); OR
-- Guided relaxation: you will watch instructional videos every day for 6 weeks; OR
-- Usual care: you will continue doing what you are doing for pain relief
After 6 weeks, we might ask you to continue with the pain relief approach in your assigned group or we might ask you to switch to a different approach. Your participation in the study will last for up to 24 weeks.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Weekends
Evenings
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE): UH3-Phase 2
Principal Investigator
Nirmish
Shah
Protocol Number
PRO00108370
NCT ID
NCT04906447
Enrollment Status
OPEN TO ACCRUAL