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Идёт набор NCT07609186

Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients

Без фазы С лечением Cataract Binaural Beats Geriatric Anesthesia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: binaural beats, sham earphone.
Кому может быть актуально
Состояния в реестре: Cataract, Binaural Beats, Geriatric Anesthesia. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation on Postoperative Patient Satisfaction in Geriatric Patients: a Single-blind, Randomized Controlled Trial

Обзор

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.

Вмешательства

  • Устройство binaural 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.
  • Устройство sham 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.

Первичные конечные точки

  • Overall Patient Satisfaction [Срок оценки: Immediately after surgery in the recovery room]
Вторичные конечные точки (5)
  • Preference for the Same Anesthesia Method [Срок оценки: Immediately after surgery in the recovery room]
  • Intraoperative Anxiety Level (VAS) [Срок оценки: Immediately after surgery in the recovery room]
  • Intraoperative Sedation Level (VAS) [Срок оценки: Immediately after surgery in the recovery room]
  • Intraoperative Pain Intensity (VAS) [Срок оценки: Immediately after surgery in the recovery room]
  • Postoperative Quality of Life (EQ-VAS) [Срок оценки: Immediately after surgery in the recovery room]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

South Korea · 1 центр
  • Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT07609186 · BB_cataract

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗