GRACE Study (Sickle Cell Disease Pain)

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.

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?

Description

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.

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 Enrollment
ClinicalTrials.gov