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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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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.
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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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001523 | Mental Disorders |