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临床试验/NCT04595344
NCT04595344已完成不适用

Effects of Listening to Binaural Beats on Anxiety Levels and Pain Scores in Male Patients Undergoing Cystoscopy and Ureteral Stent Removal: A Randomized Placebo-controlled Trial

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2019年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
352
试验地点
1
主要终点
Binaural beats and anxiety levels

研究概览

简要总结

This study aimed to investigate the effects of pure binaural beats on anxiety levels and pain scores using the State-Trait Anxiety Inventory (STAI) questionnaire and Visual Analog Scale (VAS) in male patients undergoing DC and USR procedures under local anesthesia.

详细描述

Diagnostic cystoscopy (DC) and ureteral stent removal (USR) are two common simple procedures in urology practice. DC is generally performed to investigate the etiology of hematuria, recurrent urinary tract infections, lower urinary tract symptoms, and suspected bladder tumor cases.Ureteral stent removal is usually carried out after the placed urethral stent for the treatment of urolithiasis and urethral stricture. In many urology clinics, both procedures are generally performed under local anesthesia. To reduce pain, it is recommended that DC should be performed using a flexible cystoscope. In many urology clinics, USR is performed using a rigid cystoscope in both sexes, as a rigid cystoscope is easier to manipulate during stent removal compared with a flexible cystoscope. Although performed under local anesthesia, both procedures are invasive and can cause increased anxiety levels and pain perception.Anxiety is commonly associated with an increased perception of pain.Therefore, patients who have high anxiety levels experience longer pain and require more analgesics.

Binaural beats have been recommended to reduce anxiety levels and the perception of pain in many treatment modalities.hey were discovered by Dove in 1841 and described in detail by Oster in 1973. Binaural beats are resulted from exposing each ear to two sounds which have steady intensities with different frequencies. A single tone with a midway frequency between the carrier tones is perceived. This frequency also waxes and wanes in amplitudes at a rate equal to the difference between the carrier tones It has been suggested that the human brain alters its dominant wave frequency toward that of the frequency of external stimuli to synchronize neural activity with stimuli from binaural beats.

METHOD

Ethics statement and participant selection

The study was approved by the institutional review board (Approval number and date: 16/15 - 04/07/2019 ). Male patients aged ≥ 18 y with negative urine culture, at least formal schooling (1-8 y of education) who had undergone local DC for various reasons (e.g., hematuria, carcinoma suspicion, follow-up for bladder cancer, and screening of the urethra or prostate) or unilateral USR were included in the study. Informed consent was provided by all the patients who accepted to participate in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patient
  • negative urine culture
  • at least formal schooling (1-8 y of education)

排除标准

  • hearing or vision problems
  • neurological deficits
  • mental retardation
  • history of chronic pelvic pain syndrome
  • history of previous DC or USR procedures
  • antidepressant use or analgesia use 24 h before the procedure
  • decline to participate

结局指标

主要结局

Binaural beats and anxiety levels

时间窗: 10 minutes

Effects of listening to binaural beats on axiety levels before diagnostic cystoscopy and ureteral stent removal procedures. STAI was used to assess the anxiety levels of the patients. STAI scores range from 20 to 80. Higher STAI scores indicate increased anxiety levels

Binaural beats and pain scores

时间窗: 8 minute

Effects of listening to binaural beats on pain scores during diagnostic cystoscopy and ureteral stent removal procedures. VAS vas used to assess the pain scores of patients. The VAS is a common tool in which patients score their pain level on a scale between 0 (no pain) and 10 ( worst pain possible).

次要结局

  • Classical Music and anxiety levels.(10 minutes)
  • Classical music and pain scores(8 minutes)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mahmut Taha Olcucu

Asst. Prof.

Antalya Training and Research Hospital

研究点 (1)

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