Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients
19. mai 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jeong-Hwa Seo, MD, PhD
- Telefonnummer: 82-2-2072-0641
- E-post: eong77@snu.ac.kr
Studiesteder
-
-
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Seoul, Sør -Korea
- Rekruttering
- Seoul National University Hospital
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Ta kontakt med:
- Jeong-Hwa Seo, MD, PhD
- Telefonnummer: 82-2-2072-0641
- E-post: eong77@snu.ac.kr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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.
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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Immediately after surgery in the recovery room
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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Immediately after surgery in the recovery room
|
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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.
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Immediately after surgery in the recovery room
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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.
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Immediately after surgery in the recovery room
|
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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.
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Immediately after surgery in the recovery room
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. august 2025
Primær fullføring (Antatt)
1. juli 2026
Studiet fullført (Antatt)
8. juli 2026
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
19. mai 2026
Først lagt ut (Faktiske)
27. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BB_cataract
Plan for individuelle deltakerdata (IPD)
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