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Purpose: To evaluate the evidence from randomized clinical trials (RCTs) about the effect of music intervention in reducing patients' anxiety during breast biopsy.Methods: Electronic databases including PubMed, Cochrane Library, Scopus, and Web of Science were searched using the relevant MeSH terms. The inclusion criteria were all RCTs assessing the effect of music therapy versus no music in reducing anxiety during breast biopsy. The extracted outcomes were anxiety and pain during breast biopsy. They were pooled as mean difference (MD) with a 95% confidence interval (CI) in a fixed-effects model, using Review Manager 5.3 software for windows. The quality of included studies was assessed with the Cochrane risk of bias assessment tool (RoB 1.0). Then, the outcomes of our meta-analyses were independently evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to know the grade of their evidence.Results: The final analysis included five RCTs. We found a positive effect of music therapy in reducing anxiety levels compared with control group (MD =  - 2.11; 95% CI (- 4.16 to - 0.06); p = 0.04). No difference between music and control groups regarding pain associated with breast biopsy (MD = 0.22; 95% CI (- 0.81 to 1.25); p = 0.68). The GRADE rating of our outcomes was low for anxiety levels and very low for pain during the biopsy.Conclusions: Music therapy could be an effective, simple, non-pharmacological option in relieving anxiety during breast biopsy; however, it had no effect on procedure-associated pain. More large and high-quality studies are needed to confirm our results. [ABSTRACT FROM AUTHOR]