Active Noise Cancellation Headphones on Anxiety and Autonomic Function During Rotational Atherectomy: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in State Anxiety Score from Baseline to Post-Procedure (S-AI Change Score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •Voluntary participation with written informed consent.
排除标准
- •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.
结局指标
主要结局
Change in State Anxiety Score from Baseline to Post-Procedure (S-AI Change Score)
时间窗: 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).
次要结局
- 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)
- Maximum Mean Arterial Pressure (MAP) Fluctuation Amplitude During Rotational Atherectomy(during the rotational atherectomy procedure)
- Maximum Heart Rate (HR) Fluctuation Amplitude During Rotational Atherectomy(during the rotational atherectomy procedure)
- Incidence of Symptomatic Coronary Artery Spasm During Rotational Atherectomy(during the rotational atherectomy procedure)
- Cumulative Intraoperative Dose of Vasodilator Agents (Nitroglycerin, Adenosine)(during the rotational atherectomy procedure)