HRV-B for Symptom Management in Sickle Cell Patients

NCT03383913 | Completed

• 1 other identifier: Pro00066320
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Heart Rate Variability Biofeedback; Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sleep Quality

  4-6 weeks

• C-Reactive Protein in saliva

  4-6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Heart Rate Variability Biofeedback BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• SCD patients
• years old
• English literate
• Patient recruited through Greenville Health System
• Any race or ethnicity
• Any sex

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• University of South Carolina: collaborator

Study Sites (1)

Center for Integrative Oncology and Survivorship

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aniket Saha, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: December 27, 2017
• Study Start: January 22, 2018
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)