Can headphones silence the stress of a noisy heart procedure?
NCT ID NCT07707843
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This trial investigates whether wearing AI-powered active noise-cancelling headphones during rotational atherectomy — a heart procedure that generates loud drilling noise — can reduce patient anxiety and improve heart rate stability. One hundred adults with severe coronary artery calcification will be randomly assigned to either wear the headphones or receive standard care. The study measures changes in anxiety scores, heart rate variability, and blood pressure to see if blocking the noise makes the procedure less stressful.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AI-powered active noise-cancelling headphones (Sony WH-1000XM6) worn during the procedure
- What this could lead to
- If effective, wearing noise-cancelling headphones during loud medical procedures could become a simple, drug-free way to lower patient anxiety and improve comfort.
- What could go wrong
- This is a small, early-stage trial with 100 participants, so results may not apply to all patients. The headphones may not significantly reduce anxiety or could be uncomfortable during the procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Jan 2026
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-80 years. 2. Angiographically confirmed severe coronary calcification requiring RA under local anesthesia. 3. Whisper test passed, confirming adequate communication ability. 4. Clear consciousness with Mini-Mental State Examination (MMSE) score \>= 27. 5. Voluntary participation with written informed consent. Exclusion Criteria: 1. Moderate-to-severe hearing impairment or bilateral ear conditions precluding headphone use. 2. Severe neurological disease or history of psychiatric disorders. 3. Emergency surgery, cardiogenic shock, or extreme preoperative hemodynamic instability. 4. Use of sedatives or anxiolytics within 24 hours before the procedure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
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Other studies related to the condition(s) this trial covers.
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