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Active, Not Recruiting

NCT Number: NCT07296731

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou First People's Hospital

Guangzhou, 510180, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Music intervention

Behavioral

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

No music intervention

Behavioral

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

Primary outcomes

  1. Salivary Cortisol Levels

    Time frame: 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)

  2. SATI simplified questionnaire

    Time frame: Operational day

    Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe)

  3. Visual Analog Scale

    Time frame: Operational day

    Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety)

Secondary outcomes

  1. Blood pressure

    Time frame: Operational day

    Blood pressure is continuously monitored and recorded in mmHg in the operating room

  2. Intraoperative Pain

    Time frame: Operational day

    Pain intensity was quantified using a VAS (0-10, 0 = no pain, 10 = worst pain)

  3. Heart rate

    Time frame: Operational day

    Heart rate is continuously monitored and recorded in beats per minute in the operating room

  4. Respiratory rate

    Time frame: Operational day

    Respiratory rate is continuously monitored and recorded in breaths per minute in the operating room

  5. The patient's cooperation

    Time frame: Operational day

    The patient's cooperation was assessed by the operating surgeon on a 4-point scale (4=Very Cooperative, 1=Poorly Cooperative).

Sponsors and collaborators

Lead sponsor

Guangzhou First People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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