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临床试验/NCT02764294
NCT02764294已完成不适用

Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction During Cystoscopy

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi0 个研究点目标入组 120 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
Pain Measure

研究概览

简要总结

Cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction before and during the procedure. Especially male patients feel more pain than females during cystoscopy. The aim of this study is to compare effectiveness of three different distraction methods on pain, anxiety and satisfaction of the male patients during cystoscopy.

详细描述

Cystoscopy is a reliable and effective method used commonly to investigate tumors and pathological or suspicious views related to bladder and urethra. The patients may feel pain, anxiety and dissatisfaction when cystoscope is inserted into the bladder. Thus nonpharmacological and pharmacological methods are used to decrease pain, anxiety and dissatisfaction levels of the patients during the procedure. Music is the most commonly used distraction method during cystoscopy, but there are few studies in this issue (only music) on literature. In additon, there isn't any study related to stress ball use during cystoscopy and there isn't any study which comparatives effectiveness of the multiple distraction methods to reduce pain, anxiety and dissatisfaction levels during this procedure. Therefore the investigators aimed to compare effectiveness of three different distraction methods (music, stress ball and DVD) on pain, anxiety and satisfaction of the patients during cystoscopy.

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

入选标准

  • to be male and over 18 years old
  • to be first csytoscopy
  • to be rigid csytoscopy

排除标准

  • to have a contradiction for csystoscopy (lidocaine allergies, urinary tract infection, no anatomical problems with the urethra etc.)
  • to be used any analgesic drug at least 24 hours prior to cystoscopy
  • to be made manipulations such as double j stent placement or removal, and bladder biopsy

研究组 & 干预措施

Music Group

Active Comparator

Music group was listened to a music of their choise with a headset. The music intervention was started about 10-15 minutes before cystoscopy and continued during the whole procedure. Types of music were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.

干预措施: Music Group (Other)

Stress Ball Group

Active Comparator

Stress ball group was given stress ball into both their palms about 10-15 minutes before cystoscopy. Participants were instructed to "squeeze the balls twice after counting up to five" and "repeat it until the end of the procedure".

干预措施: Stress Ball Group (Other)

DVD Group

Active Comparator

DVD group was watched a DVD of their choice (documentaries, interesting and amazing videos, comedies) on a ceiling-mounted monitor positioned at a comfortable distance to the participant.

干预措施: DVD Group (Other)

Control Group

No Intervention

Participants received usual care from health professionals. They didn't receive any intervention.

结局指标

主要结局

Pain Measure

时间窗: "5-10 minutes before", "during" and "5 minutes after" cytoscopy

The average score change on pain intensity as measured by VAS scale.

次要结局

  • Anxiety Measure("5-10 minutes before" and "5 minutes after" cytoscopy)
  • Satisfaction Measure("5 minutes after" cytoscopy)

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Gezginci

RN, PhD

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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