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Anxiety in Cataract Patients Using Preoperative Music Therapy

NCT ID: NCT07296731

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataract Music Therapy

Keywords

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Cataract Music therapy Preoperative anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental:Music therapy

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

Group Type ACTIVE_COMPARATOR

Music intervention

Intervention Type BEHAVIORAL

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

Control group (without music therapy)

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

Group Type PLACEBO_COMPARATOR

No music intervention

Intervention Type BEHAVIORAL

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

Interventions

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Music intervention

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

Intervention Type BEHAVIORAL

No music intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuehong Zhang

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First People's Hosipital

Locations

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Guangzhou First People's Hospital

Guangzhou, Guangzhou, China

Site Status

Countries

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China

Other Identifiers

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k-2025-073-01

Identifier Type: -

Identifier Source: org_study_id