Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: binaural beats, sham earphone.
- Who it may be relevant to
- Registry conditions: Cataract, Binaural Beats, Geriatric Anesthesia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation on Postoperative Patient Satisfaction in Geriatric Patients: a Single-blind, Randomized Controlled Trial
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.
Interventions
- Device binaural beats
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. - Device sham earphone
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.
Primary outcome measures
- Overall Patient Satisfaction [Time frame: Immediately after surgery in the recovery room]
Secondary outcome measures (5)
- Preference for the Same Anesthesia Method [Time frame: Immediately after surgery in the recovery room]
- Intraoperative Anxiety Level (VAS) [Time frame: Immediately after surgery in the recovery room]
- Intraoperative Sedation Level (VAS) [Time frame: Immediately after surgery in the recovery room]
- Intraoperative Pain Intensity (VAS) [Time frame: Immediately after surgery in the recovery room]
- Postoperative Quality of Life (EQ-VAS) [Time frame: Immediately after surgery in the recovery room]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07609186 · BB_cataract