HRV-B for Symptom Management in Sickle Cell Patients
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 10 - Any |
| Updated: | 2/17/2019 |
| Start Date: | January 22, 2018 |
| End Date: | August 2019 |
Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention
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 specific aims of this study are to: (1) conduct a randomized, wait list controlled,
pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD
participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain,
stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether
increases in HRV coherence are associated improvements in pain, stress, fatigue, depression,
or sleep among study participants.
autonomic balance and reduces pain and other symptoms among patients with sickle cell disease
(SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled,
pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD
participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain,
stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether
increases in HRV coherence are associated improvements in pain, stress, fatigue, depression,
or sleep among study participants.
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 pain medication dependence. HRV-B is an interactive procedure in which
participants relax and breathe regularly while watching a computer screen. The computer
screen provides feedback that helps people increase their heart rate variability, which is
the difference from beat to beat. HRV-B is a complementary, non-pharmacologic therapy that is
now being used to see if it can help sickle cell patients reduce their symptoms of pain,
stress, insomnia, fatigue, or depression.
Participants will be randomly assigned to either an Intervention Group or a Comparison Group.
Each group will have about 15-20 participants. The Intervention group will receive a baseline
assessment including symptom questionnaires, up to six weekly HRV-B training sessions lasting
about 45 minutes each, and a follow-up assessment including symptom questionnaires. There are
6-8 total visits for the intervention group and 2 for the control group. The Comparison Group
will have a baseline assessment including symptom questionnaires, then six weeks with no
training sessions, then a follow up assessment including symptom questionnaires. After the
follow up assessment, the Comparison Group members will have the option of receiving the same
treatment as the Intervention Group.
chronic pain, stress, depression, anxiety, insomnia, loneliness, helplessness, physical
limitations and pain medication dependence. HRV-B is an interactive procedure in which
participants relax and breathe regularly while watching a computer screen. The computer
screen provides feedback that helps people increase their heart rate variability, which is
the difference from beat to beat. HRV-B is a complementary, non-pharmacologic therapy that is
now being used to see if it can help sickle cell patients reduce their symptoms of pain,
stress, insomnia, fatigue, or depression.
Participants will be randomly assigned to either an Intervention Group or a Comparison Group.
Each group will have about 15-20 participants. The Intervention group will receive a baseline
assessment including symptom questionnaires, up to six weekly HRV-B training sessions lasting
about 45 minutes each, and a follow-up assessment including symptom questionnaires. There are
6-8 total visits for the intervention group and 2 for the control group. The Comparison Group
will have a baseline assessment including symptom questionnaires, then six weeks with no
training sessions, then a follow up assessment including symptom questionnaires. After the
follow up assessment, the Comparison Group members will have the option of receiving the same
treatment as the Intervention Group.
Inclusion Criteria:
- SCD patients
- 10 years old
- English literate
- Patient recruited through Greenville Health System
- Any race or ethnicity
- Any sex
Exclusion Criteria:
- 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
We found this trial at
1
site
890 West Faris Road
Greenville, South Carolina 29605
Greenville, South Carolina 29605
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