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HRV-B for Symptom Management in Sickle Cell Patients

NCT03383913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of South Carolina

    collaborator OTHER

  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Aniket Saha, MD · Prisma Health-Upstate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2018-12-28
Completion
2018-12-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383913 on ClinicalTrials.gov