Anxiety in Cataract Patients Using Preoperative Music Therapy

Research on Interventions for Anxiety in Cataract Patients Using Preoperative Music Therapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract; Music Therapy
• Intervention / Treatment: Behavioral: Music intervention; Behavioral: No music intervention

Detailed Description

This is a single-center, randomized controlled single-blind trial. Computer-generated randomization will be used to allocate patients into two groups: a control group (without music therapy) and music therapy group A (listening to music preoperatively). Patient anxiety levels, pain intensity, satisfaction with the surgical procedure, and degree of cooperation during surgery will be assessed through preoperative and postoperative questionnaires and salivary cortisol measurements. Blood pressure and heart rate will be monitored both preoperatively and intraoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510180
      • Guangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental:Music therapy; The patient listened to the selected music through headphones fifteen minutes before the operation.	Behavioral: Music intervention; Patients listen to the selected music through headphones fifteen minutes before the operation.
Placebo Comparator: Control group (without music therapy); Patients wore headphones 15 minutes before the operation, but no music was played.	Behavioral: No music intervention; Patients wore headphones 15 minutes before the operation, but no music was played.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Cortisol Levels	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)	Operational day
SATI simplified questionnaire	Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe)	Operational day
Visual Analog Scale	Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety)	Operational day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure is continuously monitored and recorded in mmHg in the operating room	Operational day
Intraoperative Pain	Pain intensity was quantified using a VAS (0-10, 0 = no pain, 10 = worst pain)	Operational day
Heart rate	Heart rate is continuously monitored and recorded in beats per minute in the operating room	Operational day
Respiratory rate	Respiratory rate is continuously monitored and recorded in breaths per minute in the operating room	Operational day
The patient's cooperation	The patient's cooperation was assessed by the operating surgeon on a 4-point scale (4=Very Cooperative, 1=Poorly Cooperative).	Operational day

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital
• Investigators: Principal Investigator: Yuehong Zhang, Guangzhou First People's Hosipital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cataract; Music therapy; Preoperative anxiety
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: k-2025-073-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No