Binaural Beats, Cataract, Geriatric Anesthesia
Conditions
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.
Interventions
DEVICEbinaural 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.
DEVICEsham 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Patient Satisfaction | Immediately after surgery in the recovery room | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preference for the Same Anesthesia Method | Immediately after surgery in the recovery room | 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. |
| Intraoperative Anxiety Level (VAS) | Immediately after surgery in the recovery room | 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. |
| Intraoperative Sedation Level (VAS) | Immediately after surgery in the recovery room | 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. |
| Intraoperative Pain Intensity (VAS) | Immediately after surgery in the recovery room | 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. |
| Postoperative Quality of Life (EQ-VAS) | Immediately after surgery in the recovery room | 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. |
Countries
South Korea
Contacts
CONTACTJeong-Hwa Seo, MD, PhD
Outcome results
None listed