NCT07707843Completed
AI ANC Headphones in Rotational Atherectomy
Active Noise Cancellation Headphones on Anxiety and Autonomic Function During Rotational Atherectomy: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 2 Jul 2026
- Start date
- 9 Jan 2026
- Primary completion date
- 26 Jun 2026
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Coronary artery disease
- NCT number
- NCT07707843
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 9 Jan 2026 to the primary completion date, 26 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery, cardiogenic shock, or extreme preoperative hemodynamic instability.
Other illness
- Moderate-to-severe hearing impairment or bilateral ear conditions precluding headphone use.
- Severe neurological disease or history of psychiatric disorders.
Other
- Use of sedatives or anxiolytics within 24 hours before the procedure.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.