AI ANC Headphones in Rotational Atherectomy

Qilu Hospital of Shandong University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Outcomes

Primary Outcomes

Change in State Anxiety Score from Baseline to Post-Procedure (S-AI Change Score)

State anxiety is assessed using the state subscale of the Chinese version of the State-Trait Anxiety Inventory (STAI Form Y; Spielberger et al., 1983). The S-AI comprises 20 items each rated on a 4-point Likert scale (total score range: 20-80), with higher scores indicating greater state anxiety. Internal consistency (Cronbach's alpha) = 0.83-0.93. The scale is administered at two time points: Baseline (T0) - after admission to the preoperative area and before initiation of rotational atherectomy; Post-procedure (T1) - after sheath removal and before leaving the catheterization laboratory. The primary metric is the change score: delta S-AI = T1 minus T0 (negative values indicate anxiety reduction).

Time frame: baseline (pre-procedure) and immediately after the procedure

Secondary Outcomes

Perceived Noise Disturbance on Visual Analogue Scale (VAS)

immediately after the procedure, the patient rates: "How disturbing was the procedural noise?" on a 1-10 horizontal VAS (1 = not disturbing at all; 10 = extremely disturbing)

Time frame: immediately after the procedure

Overall Procedural Satisfaction on Visual Analogue Scale (VAS)

immediately after the procedure, the patient rates overall satisfaction with the procedural experience on a 1-10 VAS (1 = completely dissatisfied; 10 = completely satisfied).

Time frame: immediately after the procedure

Standard Deviation of Normal-to-Normal R-R Intervals (SDNN) During Rotational Atherectomy

Continuous beat-to-beat R-R interval data (at least 5 minutes) recorded throughout the Rotational Atherectomy procedure using the Polar H10 chest strap (sampling rate: 1000 Hz). Raw data analyzed using Kubios HRV Scientific version 4.3 (Kubios Oy, Kuopio, Finland) with automatic artefact correction at the 'Very Low' threshold. SDNN reflects overall autonomic regulatory capacity.