Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02426476 · ClinicalTrials.gov registry record · NA
HRV Biofeedback in Pain Patients
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 116
- Enrollment target
NCT02426476: Completed NA study, sponsored by VA Office of Research and Development.
NCT02426476 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 116 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02426476, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 116 participants
- Enrollment target
Study Summary
Pain initiates a stress response that increases sympathetic output and leads to autonomic imbalance. Heart rate variability (HRV) is a easy to perform, valid measure of autonomic function. HRV biofeedback (HRV-B) is a novel biobehavioral procedure in which patients learn to restore autonomic balance by developing 'HRV Coherence'. Patients in HRV Coherence have improved mood and cognition. The investigators' pilot study showed that HRV-B alleviated chronic pain and stress among Veteran Pain Clinic patients. HRV-B thus has a pivotal role in managing pain. The proposed project is a randomized, sham-controlled, biobehavioral intervention with HRV-B to test the hypotheses that HRV-B increases HRV coherence and reduces pain, stress, fatigue, insomnia and depression and improves sleep, activity, and cognition in Veterans with chronic neuromuscular pain. The investigators hypothesize that HRV-B will (1) reduce self-reported pain and stress ratings, (2) improve objective measures of actigraphic sleep parameters (sleep latency, duration, efficiency, fragmentation), rest/activity rhythms (dichotomy index, interdaily stability) and cognitive function (reaction time, attention); and (3) alleviate self-reported fatigue and depression symptoms. Patients from two groups will be randomized to the investigators' previously established HRV-B or sham protocol (n=40 each), and will complete a baseline assessment, 6 weekly training sessions, a post-training assessment, and 4-week and 8-week follow-up evaluations post-training. Portable, hand-held, data-logging devices will be used to practice attaining HRV coherence at home by the active HRV-B training group, while those in the sham training group will get a 'stress squeeze ball'. Standard methods will quantify HRV coherence and other HRV measures, and validated instruments will be used to assess pain, stress, fatigue, insomnia, depression, and cognitive function. Wrist actigraphy will be used to objectively characterize insomnia via con
Interventions
- BEHAVIORAL active heart rate variability biofeedback training
- BEHAVIORAL sham HRVB training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2015-06-10 |
| Est. Completion | 2020-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02426476
The ClinicalTrials.gov registry entry for NCT02426476 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which active heart rate variability biofeedback training is the first listed.
NCT02426476 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02426476 about?
NCT02426476 is a clinical study titled "HRV Biofeedback in Pain Patients". Pain initiates a stress response that increases sympathetic output and leads to autonomic imbalance. Heart rate variability (HRV) is a easy to perform, valid measure of autonomic function. HRV biofeedback (HRV-B) is a novel biobehavioral procedure in which patients learn to restore autonomic balance...
What is the current status of trial NCT02426476?
This trial is currently completed. It is a NA study. The enrollment target is 116 participants. The study started on 2015-06-10. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT02426476?
The interventions under investigation include: active heart rate variability biofeedback training (BEHAVIORAL), sham HRVB training (BEHAVIORAL).
Who is sponsoring clinical trial NCT02426476?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
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, the data changelog, or report a data error.