HRV-B for Symptom Management in Sickle Cell Patients

Sickle Cell Disease Clinical Trial

Official title:

Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383913
• Other study ID #: Pro00066320
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: December 28, 2018

Study information

• Verified date: February 2019
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 28, 2018
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Integrative Oncology and Survivorship	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Outcomes Measurement Information System (PROMIS) Measures	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.	4-6 weeks
Secondary	Sleep Quality	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	4-6 weeks
Secondary	C-Reactive Protein in saliva	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.	4-6 weeks