Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSeoul National University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
binaural beats
DeviceThe 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 earphone
DevicePatients will wear identical earphones to the experimental group, but no sound, binaural beats, or any other auditory stimulus will be provided during the procedure.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: binaural beatsExperimental treatment 1 intervention
Group B: controlSham comparator 1 intervention
Trial outcomes
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.
Time frame
Immediately after surgery in the recovery roomSecondary outcomes
1
Preference for the Same Anesthesia Method
Patients' willingness to choose the exact same anesthesia method if they were to undergo identical surgery in the future, assessed using a 7-point Likert scale. The scale ranges from 1 to 7, where 1 indicates "Strongly disagree," 4 indicates "Neutral," and 7 indicates "Strongly agree." Higher scores indicate a stronger preference for the experienced anesthesia method.
Time frame
Immediately after surgery in the recovery room2
Intraoperative Anxiety Level (VAS)
The level of anxiety experienced during the surgery, measured retrospectively using a Visual Analogue Scale (VAS). The scale ranges from 0 to 100, where 0 represents "No anxiety at all" and 100 represents "The most severe anxiety imaginable." Higher scores indicate a higher level of anxiety.
Time frame
Immediately after surgery in the recovery room3
Intraoperative Sedation Level (VAS)
The subjective level of sedation or sleepiness experienced during the surgery, measured retrospectively using a Visual Analogue Scale (VAS). The scale ranges from 0 to 100, where 0 represents "Not sleepy at all" and 100 represents "The most severe sleepiness imaginable." Higher scores indicate a deeper subjective feeling of sedation.
Time frame
Immediately after surgery in the recovery room4
Intraoperative Pain Intensity (VAS)
The intensity of pain experienced during the surgery, measured retrospectively using a Visual Analogue Scale (VAS). The scale ranges from 0 to 100, where 0 represents "No pain at all" and 100 represents "The most severe pain imaginable." Higher scores indicate greater pain intensity.
Time frame
Immediately after surgery in the recovery roomSponsors and contacts
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Source ClinicalTrials.gov