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

NCT07609186 | Recruiting

• 1 other identifier: BB_cataract
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract; Binaural Beats; Geriatric Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after surgery in the recovery room

Secondary Outcomes (5)

• Preference for the Same Anesthesia Method

  Immediately after surgery in the recovery room

• Intraoperative Anxiety Level (VAS)

  Immediately after surgery in the recovery room

• Intraoperative Sedation Level (VAS)

  Immediately after surgery in the recovery room

• Intraoperative Pain Intensity (VAS)

  Immediately after surgery in the recovery room

• Postoperative Quality of Life (EQ-VAS)

  Immediately after surgery in the recovery room

Study Arms (2)

binaural beats

EXPERIMENTAL

Patients in this arm will wear earphones and receive binaural beat auditory stimulation continuously from the moment they arrive at the operating room until the end of the surgery. During the procedure, monitored anesthesia care (MAC) will be maintained using a propofol target-controlled infusion (TCI) at an effect-site concentration of 0.3 μg/mL.

Device: binaural beats

control

SHAM COMPARATOR

Patients in this arm will wear identical earphones to the experimental group from the moment they arrive at the operating room until the end of the surgery, but no sound or auditory stimulus will be provided. During the procedure, monitored anesthesia care (MAC) will be maintained using a propofol target-controlled infusion (TCI) at an effect-site concentration of 0.3 μg/mL.

Device: sham earphone

Interventions

binaural beats DEVICE

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.

binaural beats

sham earphone DEVICE

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.

control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Jeong-Hwa Seo, MD, PhD

CONTACT

82-2-2072-0641; eong77@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 27, 2026
• Study Start: August 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 8, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

KR (1)