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Completed

NCT Number: NCT07707843

AI ANC Headphones in Rotational Atherectomy

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.

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Key information

Conditions

Coronary Artery Disease Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Mental Disorders Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6)

Device

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.

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Perceived Noise Disturbance on Visual Analogue Scale (VAS)

    Time frame: immediately after the procedure

    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)

  2. Overall Procedural Satisfaction on Visual Analogue Scale (VAS)

    Time frame: immediately after the procedure

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

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

    Time frame: during the rotational atherectomy procedure

    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.

  4. Root Mean Square of Successive R-R Interval Differences (RMSSD) During Rotational Atherectomy

    Time frame: during the rotational atherectomy procedure

    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.

  5. High-Frequency (HF) Power and Low-Frequency/High-Frequency (LF/HF) Ratio by Autoregressive (AR) Spectral Analysis During Rotational Atherectomy

    Time frame: during the rotational atherectomy procedure

    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.

  6. Maximum Mean Arterial Pressure (MAP) Fluctuation Amplitude During Rotational Atherectomy

    Time frame: during the rotational atherectomy procedure

    MAP monitored continuously via radial arterial sheath. Maximum fluctuation amplitude = maximum MAP minus minimum MAP during the RA procedure (mmHg).

  7. Maximum Heart Rate (HR) Fluctuation Amplitude During Rotational Atherectomy

    Time frame: during the rotational atherectomy procedure

    HR derived from continuous three-lead electrocardiography. Maximum fluctuation amplitude = maximum HR minus minimum HR (bpm). Mean HR and minimum/maximum HR also reported.

  8. Incidence of Symptomatic Coronary Artery Spasm During Rotational Atherectomy

    Time frame: during the rotational atherectomy procedure

    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.

  9. Cumulative Intraoperative Dose of Vasodilator Agents (Nitroglycerin, Adenosine)

    Time frame: during the rotational atherectomy procedure

    Total administered dose (micrograms) of nitroglycerin and/or adenosine during the RA procedure, abstracted from the procedural medication record.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Acronym: ANC-RA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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