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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). 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
Primary Outcome
The BPI was developed by the World Health Organization (WHO) specifically for use among cancer patients, and it has since been widely adopted for assessment of clinical pain and pain treatment effectiveness in a variety of clinical and research settings. The possible range is 0 to 10; higher scores represent more pain interference.
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 |
What the finished NCT02426476 record still lists
NCT02426476 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which active heart rate variability biofeedback training is the first listed.
NCT02426476 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02426476's enrollment target sits among peer trials
116 808th of 2000 higher than 1,191 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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