Heartrate Variability Biofeedback for Migraine Using a Smartphone Application and Sensor: A Randomized Controlled Trial
Abstract
Introduction: Although hand temperature and electromyograph biofeedback have evidence for migraine prevention, to date, no study has evaluated heartrate variability (HRV) biofeedback for migraine. Methods: 2-arm randomized trial comparing an 8-week app-based HRV biofeedback (HeartMath) to waitlist control. Feasibility/acceptability outcomes included number and duration of sessions, satisfaction, barriers and adverse events. Primary clinical outcome was Migraine-Specific Quality of Life Questionnaire (MSQv2). Results: There were 52 participants (26/arm). On average, participants randomized to the Hearthmath group completed 29 sessions (SD=29, range: 2–86) with an average length of 6:43 minutes over 36 days (SD=27, range: 0, 88) before discontinuing. 9/29 reported technology barriers. 43% said that they were likely to recommend Heartmath to others. Average MSQv2 decreases were not significant between the Heartmath and waitlist control (estimate = 0.3, 95% CI = −3.1 – 3.6). High users of Heartmath reported a reduction in MSQv2 at day 30 (−12.3 points, p=0.010) while low users did not (p=0.765). Discussion: App-based HRV biofeedback was feasible and acceptable on a time-limited basis for people with migraine. Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 52 participants or records.
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