HRV-B for Symptom Management in Sickle Cell Patients
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|ClinicalTrials.gov Identifier: NCT03383913|
Recruitment Status : Completed
First Posted : December 27, 2017
Last Update Posted : March 10, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Behavioral: Heart Rate Variability Biofeedback||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention|
|Actual Study Start Date :||January 22, 2018|
|Actual Primary Completion Date :||December 28, 2018|
|Actual Study Completion Date :||December 28, 2018|
The intervention arm baseline visit will include: Institutional Review Board (IRB) consent, PROMIS measure baseline and outcome assessments, instructions on placement of Firstbeat device and use of Firsbeat journal, resting HRV recording using Firsbeat software for 15 minutes, saliva collection, and distribution of actigraph watch to quantify sleep quality. Participants placed in the intervention arm will receive 4-6 weeks of Heart Rate Variability Biofeedback training. All measures will be repeated at the end of the six week period.
Behavioral: Heart Rate Variability Biofeedback
Over a period of 4-6 weeks participants in the intervention arm will learn a series of breathing techniques to determine Heart Rate Variability's effects on physical function, anxiety, depression, fatigue, sleep disturbance, participation in social activities, pain interference and intensity.
No Intervention: Control
The control arm baseline visit will include: Institutional Review Board (IRB) consent, PROMIS measure assessments, instructions on placement of Firstbeat device and use of Firsbeat journal, resting HRV recording using Firstbeat software for 15 minutes, saliva collection, and distribution of actigraph watch to quantify sleep quality. The control group will receive their usual care for SCD and complete baseline and post-baseline outcome assessments without any HRV-B training. All measures will be repeated at the end of the six week period.
- Patient Reported Outcomes Measurement Information System (PROMIS) Measures [ Time Frame: 4-6 weeks ]A comprehensive survey of physical function, anxiety, sleep disturbance, depression, fatigue, social roles, pain interference, and pain intensity are completed before the study begins and upon completion. Each domain is measured with a separate short form consisting of eight questions, with the exception of pain intensity, which is measured as a raw score of zero to ten. The scores of these surveys are combined. This number is then converted to a single PROMIS measure T score metric.
- Sleep Quality [ Time Frame: 4-6 weeks ]Sleep quality will be quantified using wrist actigraph monitors that will be worn by the subject for seven days at the beginning and end of the study
- C-Reactive Protein in saliva [ Time Frame: 4-6 weeks ]Protein saliva samples will be collected by participants at baseline and at followup. Using an ELISA assay kit we will quantify inflammation mediators and C-Reactive Protein.
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|Ages Eligible for Study:||10 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- SCD patients
- 10 years old
- English literate
- Patient recruited through Greenville Health System
- Any race or ethnicity
- Any sex
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383913
|United States, South Carolina|
|Center for Integrative Oncology and Survivorship|
|Greenville, South Carolina, United States, 29605|
|Principal Investigator:||Aniket Saha, MD||Prisma Health-Upstate|
|Responsible Party:||Prisma Health-Upstate|
|Other Study ID Numbers:||
|First Posted:||December 27, 2017 Key Record Dates|
|Last Update Posted:||March 10, 2021|
|Last Verified:||February 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Heart Rate Variability Biofeedback
Sickle Cell Disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn