Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients
19 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jeong-Hwa Seo, MD, PhD
- Número de teléfono: 82-2-2072-0641
- Correo electrónico: eong77@snu.ac.kr
Ubicaciones de estudio
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Seoul, Corea del Sur
- Reclutamiento
- Seoul National University Hospital
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Contacto:
- Jeong-Hwa Seo, MD, PhD
- Número de teléfono: 82-2-2072-0641
- Correo electrónico: eong77@snu.ac.kr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador falso: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Patient Satisfaction
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Preference for the Same Anesthesia Method
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de agosto de 2025
Finalización primaria (Estimado)
1 de julio de 2026
Finalización del estudio (Estimado)
8 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2026
Publicado por primera vez (Actual)
27 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BB_cataract
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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