Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT07255118
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Intervention During AEEP: A Prospective Randomized Controlled Trial
Sponsor:
İrfan Şafak Barlas
Organization:
Study Overview
Official Title:
Effect of Music Intervention on Anxiety and Pain After Anatomical Endoscopic Enucleation of the Prostate: A Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AEEP-MUSIC
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: