Music Intervention During AEEP: A Prospective Randomized Controlled Trial

NCT07255118 | Completed

• 1 other identifier: 2023-10/425
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled study investigates the effect of perioperative music listening on anxiety and postoperative pain in patients undergoing Anatomical Endoscopic Enucleation of the Prostate (AEEP) for benign prostatic hyperplasia. A total of 135 patients were randomized into two parallel groups: 67 patients listened to relaxing instrumental music during the perioperative period, while 68 patients received standard care without music. Anxiety was assessed using the State Anxiety Inventory (SAI) immediately before surgery and 2 hours postoperatively, and pain was evaluated using the Visual Analog Scale (VAS) at the postoperative 2nd hour. The study aims to determine whether a simple, non-pharmacological behavioral intervention can improve perioperative patient comfort and recovery outcomes in endoscopic prostate surgery.

Conditions

Benign Prostatic Hyperplasia; Anxiety; Postoperative Pain Management

Keywords

AEEP; Music type; Postopertive comfort; State Anxiety Inventory; Visual Analog Scale

Outcome Measures

Primary Outcomes (1)

• Change in State Anxiety Inventory (SAI) Score

  Perioperative anxiety will be measured using the State Anxiety Inventory (SAI) at two time points: immediately before surgery (baseline) and at 2 hours postoperatively. The outcome represents the change in SAI score between these two assessments.

  From baseline (immediately before surgery) to postoperative 2nd hour.

Secondary Outcomes (1)

• Postoperative Pain Score Assessed by Visual Analog Scale (VAS)

  Postoperative 2nd hour.

Study Arms (2)

Music Group

EXPERIMENTAL

Participants undergoing AEEP who listened to standardized relaxing instrumental music via headphones during the perioperative period.

Behavioral: Music intervention

Control Group (No Music)

NO INTERVENTION

Participants undergoing AEEP who received standard perioperative care without exposure to music.

Interventions

Music intervention BEHAVIORAL

Patients listened to relaxing instrumental music beginning immediately before anesthesia induction and continuing throughout the procedure.

Music Group

Eligibility Criteria

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

You may qualify if:

• male patients aged ≥40 years
• patients who underwent surgery under regional anesthesia without sedation
• patients who did not benefit from medical treatment for BPO
• preoperative International Prostate Symptom Score (IPSS) \>19
• preoperative maximum urine flow rate (Qmax) \<15 mL/sec
• post-voiding residual volume (PVR) \>50 mL.

You may not qualify if:

• patients with urethral stricture
• patients who underwent urological treatments other than laser enucleation of the prostate
• patients with urinary tract infections and/or hematuria
• patients with urinary system malignancy
• patients with a history of previous prostate surgery
• patients with neurogenic bladder
• patients with hearing impairment
• patients with psychiatric disorders or those using medications prescribed by a psychiatrist.

Sponsors & Collaborators

• İrfan Şafak Barlas: lead

Study Sites (1)

Acibadem Ankara Hospital

Ankara, Ankara, 06550, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Mental Disorders

Study Officials

• Irfan Safak Barlas, Urology Specialist

  Acibadem Ankara Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No parties were masked because the nature of the music intervention made blinding infeasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Urology Specialist, MD, FEBU

Model Details: Participants were randomly assigned to one of two parallel groups: a music intervention group receiving perioperative music listening via headphones, and a control group receiving standard perioperative care without music. Each participant received only the intervention allocated to his assigned group, and outcomes were compared between the two independent groups.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: November 28, 2025
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)