Binaural Beats During Cataract Surgery in Older Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, controlled study, patients 65 years and older undergoing first-time phacoemulsification with posterior chamber intraocular lens implantation under monitored anesthesia care are assigned to either a binaural beat group or a sham control group. The binaural beat group wears earphones and listens to binaural beats from arrival in the operating room until the procedure ends; the control group wears identical earphones but receives no auditory stimulus. Continuous monitoring includes vital signs and BIS, with postoperative assessment of overall satisfaction on a 7-point scale and secondary measures such as anesthesia method preference, intraoperative pain, and sedation. The trial aims to determine if binaural beats can improve intraoperative comfort and patient-perceived experience.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients scheduled to undergo their first phacoemulsification and posterior chamber intraocular lens implantation (PE \& PCL) under monitored anesthesia care (MAC).
* Patients aged 65 years or older.
* Patients who fully understand the study and voluntarily provide written informed consent to participate.

Exclusion Criteria:

* Patients undergoing their second consecutive PE \& PCL surgery.
* Patients with hearing loss, hearing impairment, or those who use hearing aids.
* Patients unable to wear earphones due to diseases of the external auditory canal.
* Patients who chronically use hypnotics or sedatives.
* Patients with a history of obstructive sleep apnea or a Body Mass Index of 35 kg/m² or higher.
* Patients with a history of alcohol or drug dependence.
* Patients with a history of epilepsy or seizure disorders.
* Patients who are unable to complete a written questionnaire.
* Patients deemed unsuitable for participation in the clinical trial based on the investigator's clinical judgment.

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jeong-Hwa Seo, MD, PhD
• Email: eong77@snu.ac.kr
• Phone: 82-2-2072-0641

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.