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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 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.

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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.

Conditions Studied

Sickle Cell Disease

Interventions

  • BEHAVIORAL Heart Rate Variability Biofeedback

Study Locations (1)

South Carolina

  • Center for Integrative Oncology and Survivorship - Greenville

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2018-01-22
Est. Completion 2018-12-28
Phase NA

Sponsor

Prisma Health-Upstate

67 total trials

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What the Registry Record Tells You About NCT03383913

The ClinicalTrials.gov registry entry for NCT03383913 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (95% lower). The listed sponsor is Prisma Health-Upstate, which has 67 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.