Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Cataract, Binaural Beats, Geriatric Anesthesia

In brief

The purpose of this study is to evaluate the effects of binaural beats on patient satisfaction and intraoperative comfort in patients aged 65 years or older undergoing cataract surgery (phacoemulsification and posterior chamber intraocular lens implantation) under monitored anesthesia care (MAC) with propofol. Participants are randomly assigned to either a binaural beat group or a control group. The binaural beat group will wear earphones and listen to binaural beats from the time they arrive at the operating room until the surgery is completed. The control group will wear identical earphones but will not receive any auditory stimulus. During the procedure, standard vital signs and the bispectral index (BIS) will be continuously monitored in both groups. Following the surgery, the investigators will assess the patients' overall satisfaction using a 7-point Likert scale. Secondary assessments include patient preference for the anesthesia method, intraoperative pain intensity, sedation level, anxiety level, and quality of life (EQ-VAS) measured by a visual analogue scale. Any surgery-related discomfort or adverse events will also be recorded and compared between the two groups.

Key facts

Study ID: NCT07609186
Run by: Seoul National University Hospital
People needed: 60
Starts: 2025-08-07
Expected to finish: 2026-07-08
Last updated by the study team: 2026-05-27

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Seoul National University Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.