Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients
19 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jeong-Hwa Seo, MD, PhD
- Numéro de téléphone: 82-2-2072-0641
- E-mail: eong77@snu.ac.kr
Lieux d'étude
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-
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Seoul, Corée du Sud
- Recrutement
- Seoul National University Hospital
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Contact:
- Jeong-Hwa Seo, MD, PhD
- Numéro de téléphone: 82-2-2072-0641
- E-mail: eong77@snu.ac.kr
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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|
Comparateur factice: 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.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall Patient Satisfaction
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Preference for the Same Anesthesia Method
Délai: 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.
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Immediately after surgery in the recovery room
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Intraoperative Anxiety Level (VAS)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 août 2025
Achèvement primaire (Estimé)
1 juillet 2026
Achèvement de l'étude (Estimé)
8 juillet 2026
Dates d'inscription aux études
Première soumission
12 mai 2026
Première soumission répondant aux critères de contrôle qualité
19 mai 2026
Première publication (Réel)
27 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BB_cataract
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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