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NCT03383913 · ClinicalTrials.gov registry record · NA
HRV-B for Symptom Management in Sickle Cell Patients
A NA study of Sickle Cell Disease, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03383913: Completed NA study of Sickle Cell Disease, sponsored by Prisma Health-Upstate.
NCT03383913 is a NA study of Sickle Cell Disease that has completed, run by Prisma Health-Upstate. The registered enrollment target is 15 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03383913, a NA study of Sickle Cell Disease, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Heart Rate Variability Biofeedback
Study Locations (1)
South Carolina
- Center for Integrative Oncology and Survivorship - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-01-22 |
| Est. Completion | 2018-12-28 |
| Phase | NA |
What the finished NCT03383913 record still lists
NCT03383913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Heart Rate Variability Biofeedback is the first listed.
NCT03383913 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT03383913 about?
NCT03383913 is a clinical study titled "HRV-B for Symptom Management in Sickle Cell Patients". 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 ...
What is the current status of trial NCT03383913?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2018-01-22. Estimated completion is 2018-12-28.
What conditions does trial NCT03383913 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT03383913?
The interventions under investigation include: Heart Rate Variability Biofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03383913?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03383913 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03383913's enrollment target sits among peer trials
15 185th of 213 higher than 24 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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