Clinical trial NCT03383913: HRV-B for Symptom Management in Sickle Cell Patients
Official title: Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Heart Rate Variability Biofeedback
Sickle Cell Disease
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: University of South Carolina
First posted: 2017-12-27
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Sleep Quality
timeFrame: 4-6 weeks
measure: C-Reactive Protein in saliva
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Center for Integrative Oncology and Survivorship
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Aniket Saha, MD
role: PRINCIPAL_INVESTIGATOR
References: