ClinicalTrials.Veeva

Menu

Music Intervention During AEEP: A Prospective Randomized Controlled Trial (AEEP-MUSIC)

İ

İrfan Şafak Barlas

Status

Completed

Conditions

Benign Prostatic Hyperplasia
Postoperative Pain Management
Anxiety

Treatments

Behavioral: Music intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07255118
2023-10/425

Details and patient eligibility

About

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.

Full description

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.

Enrollment

135 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

135 participants in 2 patient groups

Music Group
Experimental group
Description:
Participants undergoing AEEP who listened to standardized relaxing instrumental music via headphones during the perioperative period.
Treatment:
Behavioral: Music intervention
Control Group (No Music)
No Intervention group
Description:
Participants undergoing AEEP who received standard perioperative care without exposure to music.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems