CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
active heart rate variability biofeedback training +1 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02426476
NCT02426476N/ACompleted

HRV Biofeedback in Pain Patients: Pilot Intervention for Pain, Fatigue & Sleep

VA Office of Research and Development·interventional·Posted Apr 27, 2015·Updated Jun 2, 2021

In Brief

A clinical study evaluating active heart rate variability biofeedback training and sham HRVB training for Chronic Neuromuscular Pain. Completed, enrolled 116 participants across 1 site.

Detailed 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 continuous recordings collected 24-hrs/day over three 1-week periods (pre-training, post-training, and at the 4 week follow-up assessments. Tests measuring attention and reaction time will assess changes in cognitive performance. Data analyses will apply linear models for repeated measures to evaluate the effect of HRV-B on study outcomes, and on treatment persistence, after adjusting for confounding factors. This study will be the first to examine HRV-B for pain management among Veteran chronic pain patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 27, 2015
Enrollment StartJun 10, 2015
Primary CompletionSep 30, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 11.2 years ago

Interventions

active heart rate variability biofeedback trainingbehavioral

resonant frequency breathing, attention focusing, positive emotional state

sham HRVB trainingbehavioral

passive relaxation