Anxiety in Cataract Patients Using Preoperative Music Therapy

Guangzhou First People's Hospital

Status: Active, not recruiting

Conditions: Cataract; Music Therapy

Treatments: Behavioral: Music intervention; Behavioral: No music intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07296731

k-2025-073-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Experimental:Music therapy

Active Comparator group

Description:

The patient listened to the selected music through headphones fifteen minutes before the operation.

Treatment:

Behavioral: Music intervention

Control group (without music therapy)

Placebo Comparator group

Description:

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

Treatment:

Behavioral: No music intervention