Personalized Music for Anxiety During Cataract Surgery

NCT07767643 | Completed

• 1 other identifier: 230071
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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-State (STAI-S), 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.

Conditions

Cataract; Anxiety; Pain

Keywords

Cataract Surgery; Personalized Music; Music Intervention; Anxiety; Pain; Perioperative Nursing

Outcome Measures

Primary Outcomes (1)

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

  State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S), with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety. STAI-S was administered approximately 1 hour before surgery and immediately after surgery to evaluate perioperative state anxiety.

  Approximately 1 hour before surgery and immediately after surgery

Secondary Outcomes (1)

• Pain Intensity Assessed Using the Visual Analog Scale (VAS)

  Immediately after surgery and 2 hours after surgery

Study Arms (2)

Personalized Music Intervention Group

EXPERIMENTAL

Participants assigned to this arm received a structured personalized music intervention during cataract surgery in addition to standard perioperative care. The music intervention was individualized based on participant preferences and delivered intraoperatively for approximately 30 minutes.

Behavioral: Structured Personalized Music Intervention

Control Group

NO INTERVENTION

Participants assigned to this arm received standard perioperative care for cataract surgery without the structured personalized music intervention.

Interventions

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.

Personalized Music Intervention Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Yatagan State Hospital

Yatağan, Muğla, 48500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cataract; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kübra Yigit Gökbel, MSc

  Ege University, Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants, care providers, and outcome assessors were not blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 11, 2023
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)