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

Seoul National University Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Cataract Binaural Beats

Interventions

binaural beatsDEVICE

The auditory stimulus provided to the experimental group generates an interference wave (binaural beat) by applying a frequency difference of 1 to 4 Hz between the left and right ears. The stimulus consists of pure binaural beats without any additional background music. The volume is initiated at 60 dB, which is set to one level lower than the default output volume of the audio-generating device.

sham earphoneDEVICE

Patients will wear identical earphones to the experimental group, but no sound, binaural beats, or any other auditory stimulus will be provided during the procedure.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall Patient Satisfaction

Overall satisfaction with the surgical process is assessed using a 7-point Likert scale. Patients respond to the statement, "I am satisfied with the overall surgical process." The scale ranges from 1 to 7, where 1 indicates "Strongly disagree," 4 indicates "Neutral," and 7 indicates "Strongly agree." Higher scores represent greater overall satisfaction.