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Music Intervention During AEEP: A Prospective Randomized Controlled Trial

NCT ID: NCT07255118

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia Anxiety Postoperative Pain Management

Keywords

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AEEP Music type Postopertive comfort State Anxiety Inventory Visual Analog Scale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an open-label study. No parties were masked because the nature of the music intervention made blinding infeasible.

Study Groups

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Music Group

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

Group Type EXPERIMENTAL

Music intervention

Intervention Type BEHAVIORAL

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

Control Group (No Music)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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İrfan Şafak Barlas

OTHER

Sponsor Role lead

Responsible Party

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İrfan Şafak Barlas

Urology Specialist, MD, FEBU

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Irfan Safak Barlas, Urology Specialist

Role: PRINCIPAL_INVESTIGATOR

Acibadem Ankara Hospital

Locations

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Acibadem Ankara Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023-10/425

Identifier Type: -

Identifier Source: org_study_id