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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • binaural beats
  • sham earphone

Treatment groups

60 Participants
are divided into 2 treatment groups