Cataract Removal Clinical Trials

Clinical trials related to Cataract Removal Procedure

Effect of Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation on Postoperative Patient Satisfaction in Geriatric Patients: a Single-blind, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Jeong-Hwa Seo, MD, PhD
eong77@snu.ac.kr
82-2-2072-0641
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2026-07-08
Participants
Target number of participants: 60
Treatments
Experimental: binaural beats
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.
Sham_comparator: control
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.
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov