Efficacy of mindfulness-based interventions and biofeedback for migraine management: a systematic review and meta-analysis of randomized controlled trials

Objective This systematic review and meta-analysis of randomized controlled trials aims to analyze the efficacy of mindfulness-based interventions and biofeedback on headache frequency, pain intensity, headache-related disability, psychological distress, and quality of life in adult patients with migraine. Methods The review followed the PRISMA statement and was registered in PROSPERO (CRD420261381587). A structured search was conducted across PubMed, Scopus, and PsycInfo for RCTs published in English between May 2016 and May 2026. Seven clinical trials ( n = 535 participants) met the inclusion criteria. Methodological quality and risk of bias were evaluated using the Cochrane Risk of Bias 2 (RoB 2) tool. Results The pooled analysis for headache frequency ( n = 6 studies) showed no statistically significant differences between groups (MD = −0.59; 95% CI: −1.81 to 0.62; p = 0.34). Conversely, significant improvements favoring the experimental groups were found for headache-related disability measured with the HIT-6 scale ( n = 6 studies; MD = −2.28; 95% CI: −4.47 to −0.08; p = 0.04), pain intensity ( n = 3 studies; SMD = −0.39; 95% CI: −0.64 to −0.14; p = 0.002), and health-related quality of life ( n = 3 studies; MD = +5.21; 95% CI: 1.95 to 8.47; p = 0.002). No statistically significant differences were observed for anxiety ( p = 0.30) or depression ( p = 0.88). Conclusion Interventions incorporating Mindfulness-Based Interventions and Biofeedback do not significantly reduce objective migraine attack frequency compared to control conditions, nor do they yield distinct differences in affective outcomes (anxiety/depression)—which may partly reflect subclinical baseline depression scores in episodic cohorts, active-comparator effects, and instrument heterogeneity. However, they exhibit statistically significant efficacy in decreasing subjective pain intensity, mitigating headache-related functional disability, and restoring health-related quality of life, supporting their role as valuable complementary strategies for self-regulation and clinical coping in migraine management. Systematic review registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420261381587 , Identifier: CRD420261381587.