NCT03383913

HRV-B for Symptom Management in Sickle Cell Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-22
• Primary completion: 2018-12-28
• Completion: 2018-12-28
• First posted: 2017-12-27
• Last updated: 2024-10-28

Locations

1 site across 1 country: United States