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

19. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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-komparator: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Patient Satisfaction
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Preference for the Same Anesthesia Method
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. august 2025

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

8. juli 2026

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

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