Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients
2026年5月19日 更新者：Jeong-Hwa Seo、Seoul National University Hospital
Effect of Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation on Postoperative Patient Satisfaction in Geriatric Patients: a Single-blind, Randomized Controlled 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.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jeong-Hwa Seo, MD, PhD
- 电话号码：82-2-2072-0641
- 邮箱：eong77@snu.ac.kr
学习地点
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Seoul、韩国
- 招聘中
- Seoul National University Hospital
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接触：
- Jeong-Hwa Seo, MD, PhD
- 电话号码：82-2-2072-0641
- 邮箱：eong77@snu.ac.kr
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：binaural beats
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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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.
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假比较器：control
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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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Patient Satisfaction
大体时间：Immediately after surgery in the recovery room
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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.
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Immediately after surgery in the recovery room
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Preference for the Same Anesthesia Method
大体时间：Immediately after surgery in the recovery room
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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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Immediately after surgery in the recovery room
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Intraoperative Anxiety Level (VAS)
大体时间：Immediately after surgery in the recovery room
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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.
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Immediately after surgery in the recovery room
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Intraoperative Sedation Level (VAS)
大体时间：Immediately after surgery in the recovery room
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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.
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Immediately after surgery in the recovery room
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Intraoperative Pain Intensity (VAS)
大体时间：Immediately after surgery in the recovery room
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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.
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Immediately after surgery in the recovery room
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Postoperative Quality of Life (EQ-VAS)
大体时间：Immediately after surgery in the recovery room
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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.
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Immediately after surgery in the recovery room
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年8月7日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2026年7月8日
研究注册日期
首次提交
2026年5月12日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月19日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.