Effect of Music Intervention on Anxiety and Pain After Anatomical Endoscopic Enucleation of the Prostate: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Change in State Anxiety Inventory (SAI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study. No parties were masked because the nature of the music intervention made blinding infeasible.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Music Group
Participants undergoing AEEP who listened to standardized relaxing instrumental music via headphones during the perioperative period.
干预措施: Music intervention (Behavioral)
Control Group (No Music)
Participants undergoing AEEP who received standard perioperative care without exposure to music.
结局指标
主要结局
Change in State Anxiety Inventory (SAI) Score
时间窗: 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.
次要结局
- Postoperative Pain Score Assessed by Visual Analog Scale (VAS)(Postoperative 2nd hour.)
研究者
İrfan Şafak Barlas
Urology Specialist, MD, FEBU
Acibadem University