Effect of Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation on Postoperative Patient Satisfaction in Geriatric Patients: a Single-blind, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Jeong-Hwa Seo
Professor
Seoul National University Hospital