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NCT Number: NCT07255118

Music Intervention During AEEP: A Prospective Randomized Controlled Trial

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.

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Ankara Hospital

Ankara, 06550, Turkey (Türkiye)

About this study

Benign prostatic hyperplasia (BPH) is one of the most common urological conditions in aging men, often requiring surgical intervention when medical therapy fails. Anatomical Endoscopic Enucleation of the Prostate (AEEP) has emerged as an effective and tissue-preserving surgical approach for managing BPH. Despite the minimally invasive nature of AEEP, perioperative anxiety and postoperative pain remain important determinants of patient comfort, satisfaction, and overall recovery.

Music listening is a simple, inexpensive, and non-pharmacological behavioral intervention that has been shown in various surgical disciplines to reduce anxiety, modulate pain perception, and improve patient experience. However, its potential benefits during AEEP have not been previously explored.

In this prospective randomized controlled trial, we evaluated the effect of perioperative music exposure on anxiety and acute postoperative pain among patients undergoing AEEP. A total of 135 male patients scheduled for AEEP were enrolled and randomized into two groups:

Music Group (n = 67): Patients listened to standardized relaxing instrumental music via headphones starting immediately before anesthesia induction and continuing during the procedure.

Control Group (n = 68): Patients received routine perioperative care without exposure to music.

Perioperative anxiety was measured using the State Anxiety Inventory (SAI) at two predefined time points: immediately before surgery and at the postoperative 2nd hour. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) 2 hours after the procedure. All surgical and anesthetic techniques were standardized across groups to minimize variability.

This study aims to determine whether perioperative music listening can serve as an effective adjunctive intervention to improve psychological well-being and reduce pain in patients undergoing AEEP. Findings from this research may support the integration of music into perioperative care pathways, offering a safe and easily applicable strategy to enhance patient-centered outcomes in endoscopic prostate surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Music intervention

Behavioral

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

Primary outcomes

  1. Change in State Anxiety Inventory (SAI) Score

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

    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.

Secondary outcomes

  1. Postoperative Pain Score Assessed by Visual Analog Scale (VAS)

    Time frame: Postoperative 2nd hour.

    Pain intensity will be evaluated using a 0-10 Visual Analog Scale (VAS) at the postoperative 2nd hour.

Sponsors and collaborators

Lead sponsor

İrfan Şafak Barlas

Other

Registry information

Official study title

Effect of Music Intervention on Anxiety and Pain After Anatomical Endoscopic Enucleation of the Prostate: A Prospective Randomized Controlled Trial

Acronym: AEEP-MUSIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Nov 28, 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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