Clinical Research Directory

AI ANC Headphones in Rotational Atherectomy

Sponsor: Qilu Hospital of Shandong University

Summary

Background: Rotational atherectomy (RA) generates high-intensity drilling noise concentrated around 3000 Hz, creating a distinctive auditory stressor that may exacerbate perioperative anxiety and autonomic dysregulation in patients undergoing percutaneous coronary intervention. Despite growing evidence linking procedural noise to adverse psychological and physiological outcomes, targeted noise-reduction interventions in the cardiac catheterization laboratory remain unexplored. Aims: To investigate the effects of intraoperative artificial intelligence-enabled active noise cancellation (AI ANC) headphones on state anxiety, autonomic nerve function assessed by heart rate variability (HRV), and hemodynamic stability in patients undergoing RA. Methods: This prospective, randomized, assessor-blinded, controlled trial enrolled 100 patients undergoing elective RA between January and June 2026 at a tertiary hospital in Shandong Province, China. After screening 120 consecutive patients, 100 eligible participants were randomized 1:1 to the experimental group (AI ANC headphones \[Sony WH-1000XM6\] plus standard care, n=50) or the control group (standard care alone, n=50). The primary outcome was the change in state anxiety (S-AI) score from baseline to post-procedure. Secondary outcomes included noise disturbance visual analogue scale (VAS), patient satisfaction, HRV indices (time-domain: SDNN, RMSSD; frequency-domain by autoregressive \[AR\] model and fast Fourier transform \[FFT\] as reference), hemodynamic fluctuations (MAP, HR, SpO2), incidence of symptomatic coronary spasm, and intraoperative vasodilator consumption. Continuous ECG was recorded via Polar H10 chest strap; HRV was analyzed using Kubios HRV Scientific 4.3. All analyses followed the intention-to-treat principle.

Official title: Active Noise Cancellation Headphones on Anxiety and Autonomic Function During Rotational Atherectomy: A Randomized Trial

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