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

19 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Jeong-Hwa Seo, MD, PhD
  • Telefonnummer: 82-2-2072-0641
  • E-post: eong77@snu.ac.kr

Studieorter

  • Sydkorea
      • Seoul, Sydkorea
        • Rekrytering
        • Seoul National University Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Sham Comparator: 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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Patient Satisfaction
Tidsram: 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.
Immediately after surgery in the recovery room

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Preference for the Same Anesthesia Method
Tidsram: 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.
Immediately after surgery in the recovery room
Intraoperative Anxiety Level (VAS)
Tidsram: 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.
Immediately after surgery in the recovery room
Intraoperative Sedation Level (VAS)
Tidsram: 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.
Immediately after surgery in the recovery room
Intraoperative Pain Intensity (VAS)
Tidsram: 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.
Immediately after surgery in the recovery room
Postoperative Quality of Life (EQ-VAS)
Tidsram: 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.
Immediately after surgery in the recovery room

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Seoul National University Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 augusti 2025

Primärt slutförande (Beräknad)

1 juli 2026

Avslutad studie (Beräknad)

8 juli 2026

Studieregistreringsdatum

Först inskickad

12 maj 2026

Först inskickad som uppfyllde QC-kriterierna

19 maj 2026

Första postat (Faktisk)

27 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 maj 2026

Senast verifierad

1 maj 2026

Mer information

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