AI ANC Headphones in Rotational Atherectomy

NCT07707843 | Completed

• 1 other identifier: KYLL-2026-03-013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Active noise cancellation; Anxiety; Heart rate variability; Perioperative nursing; Hemodynamic stability; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Perceived Noise Disturbance on Visual Analogue Scale (VAS)

  immediately after the procedure

• Overall Procedural Satisfaction on Visual Analogue Scale (VAS)

  immediately after the procedure

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

  during the rotational atherectomy procedure

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

  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

  during the rotational atherectomy procedure

Study Arms (2)

AI ANC Headphones + Standard Care

EXPERIMENTAL

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)

Standard Care Alone

NO INTERVENTION

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.

Interventions

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.

AI ANC Headphones + Standard Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded: The data collector administering S-AI and VAS assessments; the HRV analyst reviewing Kubios output; the independent endpoint adjudication committee member. All assessment forms carry only participant identification codes. Non-blinded: Patients and procedural team are aware of headphone use due to the nature of the intervention. Non-blinded personnel instructed not to disclose group assignment to blinded assessors. Blinding integrity verified at study completion.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, parallel-group, assessor-blinded, randomized controlled trial. Participants are randomized 1:1 to the experimental arm (AI ANC headphones plus standard care) or the control arm (standard care alone) using computer-generated block randomization (block sizes of 4 and 6) with sequentially numbered, opaque, sealed envelopes for allocation concealment.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 16, 2026
• Study Start: January 9, 2026
• Primary Completion: June 26, 2026
• Study Completion: June 30, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-06

Locations

CN (1)