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The Analgesia Nociception Index (ANI), an objective measure of pain based on heart rate variability (HRV), has its usefulness in awake patients still unclear. This systematic review and meta-analysis aimed to assess ANI's accuracy compared to self-reported pain measures in conscious individuals undergoing medical procedures or painful stimuli. PubMed, Ovid, Web of Science, Scopus, Embase, and grey literature were searched until March 2021. Of the 832 identified citations, 16 studies complied with the eligibility criteria. A meta-analysis including nine studies demonstrated a weak negative correlation between ANI and NRS for pain assessment in individuals in the post-anesthetic recovery room (r = − 0.0984, 95% CI = − 0.397 to 0.220, I 2  = 95.82%), or in those submitted to electrical stimulus (r = − 0.089; 95% CI = − 0.390 to 0.228, I 2  = 0%). The evidence to use ANI in conscious individuals is weak compared to self-report measures of pain, yet ANI explains a part of self-report. Therefore, some individuals may be benefited from the use of ANI during procedures or in the immediate postoperative period.

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Comparison between Analgesia Nociception Index (ANI) and self-reported measures for diagnosing pain in conscious individuals: a systematic review and meta-analysis