Trial reportGeneral hospital psychiatry
Heartrate variability biofeedback for migraine using a smartphone application and sensor: A randomized controlled trial.
Trial report in General hospital psychiatry. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Interventions Based on Biofeedback Systems to Improve Workers' Psychological Well-Being, Mental Health, and Safety: Systematic Literature Review.Journal of medical Internet research · 2025Pooled it
- Behavioral interventions for migraine prevention: A systematic review and meta-analysis.Headache · 2025Pooled it
- Pooled it
- Smartphone-Based Muscle Relaxation for Migraine in the Emergency Department: A Randomized Clinical Trial.JAMA network open · 2025Trial
- A Prescribed Digital Health App and Number of Migraine Days: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Feasibility of a 12-Week, Therapist-Independent, Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: Single-Center, Open-Label, 1-Armed Trial.JMIR human factors · 2025Trial
- Heart rate variability biofeedback in patients with functional dizziness.Journal of neurology · 2025Trial
- Psychological interventions for migraine.Nature reviews. Neurology · 2026Review
- The Emerging Clinical Relevance of Artificial Intelligence, Data Science, and Wearable Devices in Headache: A Narrative Review.Life (Basel, Switzerland) · 2025Review
- Cognitive Behavioral Therapy and Biofeedback.Current pain and headache reports · 2025Review
- The impact of neuroscience education therapy, behavioral economics, and digital navigators on patient migraine treatment adherence to a mobile health application: a prospective pilot randomized controlled trial.NPP - digital psychiatry and neuroscience · 2025Article
- Experiences of a Neurofeedback-Based Mindfulness Meditation Intervention for Migraine: Qualitative Study.JMIR neurotechnology · 2025Article
- Factors Associated with Patient Adherence to Biofeedback Therapy Referral for Migraine: An Observational Study.Applied psychophysiology and biofeedback · 2024Observational
- Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial - the study protocol.F1000Research · 2024Article
- The impact of immersive virtual reality meditation for depression and anxiety among inpatients with major depressive and generalized anxiety disorders.Frontiers in psychology · 2024Article
- Alleviating premenstrual symptoms with smartphone-based heart rate variability biofeedback training: a pilot study.Frontiers in digital health · 2024Article
- Digitally Assisted Mindfulness in Training Self-Regulation Skills for Sustainable Mental Health: A Systematic Review.Behavioral sciences (Basel, Switzerland) · 2023Review
- The Role of the Autonomic Nervous System in Headache: Biomarkers and Treatment.Current pain and headache reports · 2022Review
- Relationship Between Headache Characteristics and a Remote History of TBI in Veterans: A 10-Year Retrospective Chart Review.Neurology · 2022Article
- Computerized migraine diagnostic tools: a systematic review.Therapeutic advances in chronic disease · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
introductionAlthough hand temperature and electromyograph biofeedback have evidence for migraine prevention, to date, no study has evaluated heartrate variability (HRV) biofeedback for migraine.
methods2-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).
resultsThere 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 min 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.