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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong-Hwa Seo, MD, PhD | Contact | 82-2-2072-0641 | eong77@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 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. |
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| Immediately after surgery in the recovery room |
| 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. | Immediately after surgery in the recovery room |
| 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. | Immediately after surgery in the recovery room |
| 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. | Immediately after surgery in the recovery room |
| Postoperative Quality of Life (EQ-VAS) | Patients' self-rated health status assessed using the EuroQol Visual Analogue Scale (EQ-VAS). The scale ranges from 0 to 100, where 0 represents "The worst health you can imagine" and 100 represents "The best health you can imagine." Higher scores indicate a better health-related quality of life. | Immediately after surgery in the recovery room |