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临床试验/NCT04466202
NCT04466202已完成不适用

The Effect of Music With Structured Verbal Training on Pain, Anxiety and Satisfaction During Prostate Biopsy

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
change on pain intensity as measured by Visual Analog Scale

研究概览

简要总结

Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. The aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.

详细描述

Although there have been several studies examining the effect of music on pain and / or anxiety during TRUS prostate biopsy, only one study has been found examining the effect of stress management (music and one-to-one simulation training) on patients' pain and anxiety levels. In addition, there is only one study on the effectiveness of the training method (written and video-based training) on anxiety levels of patients related to prostate biopsy. For this reason, it is thought that music will be more effective on pain and anxiety levels along with structured verbal training to alleviate the discomfort associated with patients' biopsy procedure.

研究设计

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

入排标准

年龄范围
40 Years 至 86 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • being over the age of 40
  • male gender
  • transrectal ultrasound guided prostate biopsy for the first time
  • agreeing to participate in the study

排除标准

  • presence of any contraindication for prostate biopsy
  • any analgesic used 24 hours before prostate biopsy

结局指标

主要结局

change on pain intensity as measured by Visual Analog Scale

时间窗: "just before procedure", "during procedure" and "5 minutes after procedure"

The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.

次要结局

  • score change on anxiety level as measured by State-Trait Anxiety Inventory("just before procedure" and "5 minutes after procedure")

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Gezginci

RN, PhD, Asst Prof

Saglik Bilimleri Universitesi

研究点 (1)

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