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Completed

NCT Number: NCT07767643

Personalized Music for Anxiety During Cataract Surgery

This randomized controlled trial evaluated the effect of a personalized music intervention on anxiety and pain in patients undergoing cataract surgery under local anesthesia. A total of 100 patients were randomly assigned to an intervention group or a control group. Patients in the intervention group received a structured personalized music intervention during surgery based on their musical preferences, while patients in the control group received standard care. Anxiety was assessed before and immediately after surgery using the State-Trait Anxiety Inventory (STAI), and pain was assessed immediately after surgery and two hours after surgery using the Visual Analog Scale (VAS). The study aimed to determine whether personalized music provided during cataract surgery could reduce patients' anxiety and pain compared with standard care.

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Key information

Conditions

Cataract Anxiety Anxiety Disorders Eye Diseases Lens Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yatagan State Hospital

Yatağan, Muğla, 48500, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 40-75 years
  • Able to read and write
  • Able to speak and understand Turkish
  • No psychiatric or neurological diagnosis that could affect pain or anxiety
  • Willing to participate in the study

Exclusion criteria

  • Communication problems
  • Communication impairment
  • Chronic pain
  • Psychiatric disorder
  • Substance or alcohol dependence
  • History of ear infection
  • Previous ocular surgery other than cataract surgery
  • Mature cataract, traumatic cataract, or other conditions considered likely to prolong surgery or increase the risk of complications
  • Complicated diabetes mellitus (polyneuropathy, diabetic retinopathy, or nephropathy) or HbA1c ≥8% (uncontrolled diabetes)

Treatment and study plan

Structured Personalized Music Intervention

Behavioral

Participants received a structured personalized music intervention during cataract surgery. Music was individualized according to participant preferences using a structured assessment of music preferences. Instrumental music with a tempo of approximately 60-100 beats per minute was selected and delivered in the operating room for approximately 30 minutes during surgery, in addition to standard perioperative care.

Primary outcomes

  1. State Anxiety Level Assessed Using the State-Trait Anxiety Inventory-State (STAI-S)

    Time frame: Approximately 1 hour before surgery and immediately after surgery

    State anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S). Higher scores indicate greater levels of state anxiety. STAI-S was administered approximately 1 hour before surgery and immediately after surgery to evaluate the change in perioperative anxiety.

Secondary outcomes

  1. Pain Intensity Assessed Using the Visual Analog Scale (VAS)

    Time frame: Immediately after surgery and 2 hours after surgery

    Pain intensity was assessed using the Visual Analog Scale (VAS), with higher scores indicating greater pain intensity. Pain was assessed immediately after surgery and 2 hours after surgery to evaluate postoperative pain.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Music Selected According to Patients' Musical Preferences on Anxiety and Pain During Cataract Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

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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