AI ANC Headphones in Rotational Atherectomy (ANC-RA)

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-80 years.
2. Angiographically confirmed severe coronary calcification requiring RA under local anesthesia.
3. Whisper test passed, confirming adequate communication ability.
4. Clear consciousness with Mini-Mental State Examination (MMSE) score >= 27.
5. Voluntary participation with written informed consent.

Exclusion Criteria:

1. Moderate-to-severe hearing impairment or bilateral ear conditions precluding headphone use.
2. Severe neurological disease or history of psychiatric disorders.
3. Emergency surgery, cardiogenic shock, or extreme preoperative hemodynamic instability.
4. Use of sedatives or anxiolytics within 24 hours before the procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI ANC Headphones + Standard Care; Both groups receive standardized perioperative nursing care and RA procedural protocols. In addition, patients in the experimental arm: (a) undergo pre-procedure education explaining the headphone's dual function (noise filtering + speech preservation); (b) immediately before RA initiation, a trained nurse fits the patient with Sony WH-1000XM6 headphones set to ANC mode and verifies comfort; (c) the headphones remain in place throughout the entire procedure; (d) intraoperatively, if communication difficulty arises, the nurse places their palm on the right earcup to temporarily activate conversation mode - releasing the hand restores full noise cancellation; (e) contingency: if communication remains inadequate or patient intolerance/device malfunction occurs, headphones are immediately removed (patient stays in ITT analysis). All patients wear a Polar H10 chest-strap heart rate monitor (1000 Hz sampling) for continuous ECG recording during RA.	Device: AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6); Commercially available over-ear ANC headphones with adaptive AI-driven noise cancellation and voice-passthrough mode. Set to ANC mode throughout the procedure. A palm placed on the right earcup temporarily activates conversation mode; releasing the hand restores full noise cancellation.
No Intervention: Standard Care Alone; Patients receive full, identical standardized perioperative nursing care and RA procedural protocols as the experimental arm, including verbal reassurance from the circulating nurse using standardized neutral language (to minimize performance bias). Patients wear the Polar H10 chest-strap heart rate monitor for continuous ECG recording. No noise-cancelling headphones are used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline (pre-procedure) and immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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.	during the rotational atherectomy procedure
Root Mean Square of Successive R-R Interval Differences (RMSSD) During Rotational Atherectomy	Calculated from the same at-least-5-minute R-R interval recording using Kubios HRV Scientific 4.3. RMSSD specifically captures vagally mediated beat-to-beat modulation of heart rate.	during the rotational atherectomy procedure
High-Frequency (HF) Power and Low-Frequency/High-Frequency (LF/HF) Ratio by Autoregressive (AR) Spectral Analysis During Rotational Atherectomy	Frequency-domain analysis performed using AR modeling (primary method, 16th-order model) and FFT (reference method, Welch's periodogram). HF power (0.15-0.40 Hz, ms2) primarily reflects respiratory-mediated vagal efferent activity. VLF power excluded per Task Force recommendations. Bonferroni correction (adjusted alpha = 0.00625) applied to frequency-domain indices.	during the rotational atherectomy procedure
Maximum Mean Arterial Pressure (MAP) Fluctuation Amplitude During Rotational Atherectomy	MAP monitored continuously via radial arterial sheath. Maximum fluctuation amplitude = maximum MAP minus minimum MAP during the RA procedure (mmHg).	during the rotational atherectomy procedure
Maximum Heart Rate (HR) Fluctuation Amplitude During Rotational Atherectomy	HR derived from continuous three-lead electrocardiography. Maximum fluctuation amplitude = maximum HR minus minimum HR (bpm). Mean HR and minimum/maximum HR also reported.	during the rotational atherectomy procedure
Incidence of Symptomatic Coronary Artery Spasm During Rotational Atherectomy	Defined as transient coronary lumen narrowing greater than 50 percent compared to baseline angiography, accompanied by chest pain and/or ST-segment changes, requiring vasodilator administration.	during the rotational atherectomy procedure
Cumulative Intraoperative Dose of Vasodilator Agents (Nitroglycerin, Adenosine)	Total administered dose (micrograms) of nitroglycerin and/or adenosine during the RA procedure, abstracted from the procedural medication record.	during the rotational atherectomy procedure

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Actual): June 26, 2026
• Study Completion (Actual): June 30, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Randomized controlled trial; Hemodynamic stability; Heart rate variability; Perioperative nursing; Active noise cancellation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Anxiety Disorders; Coronary Artery Disease
• Other Study ID Numbers: KYLL-2026-03-013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No