NCT07296731

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Mar 2025Jul 2027

Study Start

First participant enrolled

March 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

November 18, 2025

Last Update Submit

December 8, 2025

Conditions

CataractMusic Therapy

Keywords

CataractMusic therapyPreoperative anxiety

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Blood pressure

    Operational day

  • Intraoperative Pain

    Operational day

  • Heart rate

    Operational day

  • Respiratory rate

    Operational day

  • The patient's cooperation

    Operational day

Study Arms (2)

Experimental:Music therapy

ACTIVE COMPARATOR

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

Behavioral: Music intervention

Control group (without music therapy)

PLACEBO COMPARATOR

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

Behavioral: No music intervention

Interventions

Music interventionBEHAVIORAL

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

Experimental:Music therapy
No music interventionBEHAVIORAL

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

Control group (without music therapy)

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Requires complex and prolonged surgery, such as:
  • Shallow anterior chamber with risk of glaucoma
  • Advanced cataracts with hard nuclei
  • 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:
  • Oral contraceptives
  • Thyroid drugs
  • Steroids
  • Psychotropic drugs
  • Diagnosed with autoimmune diseases (e.g., Sjögren's syndrome) or oral diseases with inflammation/active lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangzhou, 510180, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Yuehong Zhang

    Guangzhou First People's Hosipital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 22, 2025

Study Start

March 31, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 31, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

CN(1)