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Anxiety in Cataract Patients Using Preoperative Music Therapy

NCT07296731 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-03-31
Last updated
2025-12-22

Condition(s) studied

CataractMusic Therapy

Investigational drug(s) / intervention(s)

Music interventionNo music intervention

Music intervention: Patients listen to the selected music through headphones fifteen minutes before the operation.

No music intervention: Patients wore headphones 15 minutes before the operation, but no music was played.

Study summary

The researchers designed this study to investigate whether implementing preoperative music intervention in cataract surgery can reduce perioperative anxiety, alleviate postoperative pain, and enhance patient satisfaction with the surgical procedure.

Eligibility

Sex
ALL
Min age
—
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Meets the diagnostic criteria for cataract * Age ≤ 90 years * Scheduled for phacoemulsification with IOL implantation under topical anesthesia at the Ophthalmology Department of Guangzhou First People's Hospital * Voluntarily participates and provides signed informed consent Exclusion Criteria: * Requires complex and prolonged surgery, such as: 1. Shallow anterior chamber with risk of glaucoma 2. Advanced cataracts with hard nuclei 3. Small pupils * Has hearing impairment or communication difficulties * Shows significant anxiety/depression tendencies or has a history of mental illness with prior/current use of sedatives * Refuses to participate, or has difficulty understanding/answering questionnaires, or has cognitive impairments * Uses medications that may affect cortisol and cardiovascular reactivity, including: 1. Oral contraceptives 2. Thyroid drugs 3. Steroids 4. Psychotropic drugs * Diagnosed with autoimmune diseases (e.g., Sjögren's syndrome) or oral diseases with inflammation/active lesions

Primary outcome measure(s)

  • Salivary Cortisol Levels — Operational day
    Saliva samples were collected at admission and 15 minutes postoperatively using Salivette tubes, centrifuged, and stored at -80°C. Cortisol concentrations were measured via ELISA using the R\&D Systems Cortisol Assay Kit (Cat. No. KGE008B)
  • SATI simplified questionnaire — Operational day
    Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe)
  • Visual Analog Scale — Operational day
    Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety)

Trial sites (1)

FacilityCityRegionStatus
Guangzhou First People's Hospital Guangzhou Guangzhou
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07296731 on ClinicalTrials.gov ↗ ← All trials in China