Status:
COMPLETED
HRV-B for Symptom Management in Sickle Cell Patients
Lead Sponsor:
Prisma Health-Upstate
Collaborating Sponsors:
University of South Carolina
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
10+ years
Phase:
NA
Brief Summary
This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores autonomic balance and reduces pain and other symptoms among patients with sickle cell disease (SCD).The spe...
Detailed Description
The purpose of this study is to see if Heart Rate Variability Biofeedback (HRV-B) can reduce chronic pain, stress, depression, anxiety, insomnia, loneliness, helplessness, physical limitations and pai...
Eligibility Criteria
Inclusion
- SCD patients
- 10 years old
- English literate
- Patient recruited through Greenville Health System
- Any race or ethnicity
- Any sex
Exclusion
- Conditions affecting HRV (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina)
- Medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors)
- Pacemaker or defibrillator
- Heart transplant or by-pass surgery within 1 year
- Active seizure disorder or use of antiseizure/anticonvulsant medication specifically for seizures
- Dementia
- Moderate or severe head injury or stroke within 6 months
- Evidence of active substance abuse
- An uncontrolled major psychiatric disorder
- Cognitive disability that precludes participation
- Use of long acting (extended release) opioid medications; however, 'as needed' short acting opioid medication usage is allowable
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03383913
Start Date
January 22 2018
End Date
December 28 2018
Last Update
October 28 2024
Active Locations (1)
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1
Center for Integrative Oncology and Survivorship
Greenville, South Carolina, United States, 29605