Heartrate variability biofeedback for migraine using a smartphone application and sensor: A randomized controlled trial.

Abstract

INTRODUCTION\nAlthough hand temperature and electromyograph biofeedback have evidence for migraine prevention, to date, no study has evaluated heartrate variability (HRV) biofeedback for migraine.\n\n\nMETHODS\n2-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).\n\n\nRESULTS\nThere were 52 participants (26/arm). On average, participants randomized to the Hearthmath group completed 29 sessions (SD\xa0=\xa029, range: 2-86) with an average length of 6:43\xa0min over 36\xa0days (SD\xa0=\xa027, 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\xa0=\xa00.3, 95% CI\xa0=\xa0-3.1 - 3.6). High users of Heartmath reported a reduction in MSQv2 at day 30 (-12.3 points, p\xa0=\xa00.010) while low users did not (p\xa0=\xa00.765).\n\n\nDISCUSSION\nApp-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.