The Effect of Watching Relaxing Video on Pain and Anxiety Levels of Female Patients During Cystoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 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
The cystoscopy procedure may cause pain and anxiety in patients. Since cystoscopy causes more pain in men, studies on pain and anxiety during cystoscopy are more common in men than women. The aim of this study was to evaluate the effect of watching relaxing video during cystoscopy on the pain and anxiety levels of female patients.
详细描述
Cystoscopy is a safe procedure with low risk of morbidity commonly used to evaluate lower urinary tract symptoms such as hematuria, voiding disorders, irritant bladder symptoms, anatomical disorders. Patients experience pain and anxiety when cystoscope is inserted into the bladder. The various methods (drug or non-drug) are used for pain and anxiety during the cystoscopy. Although there are a lot of studies on male patients, there are limited studies evaluating pain severity in the female patients during urological procedures. In addition, there wasn't found any randomized controlled study for video use from non-drug methods to distract attention in these patients. Based on the study results in the literature, investigators aimed to evaluate the effect of watching relaxing video on the pain and anxiety levels of female patients during rigid 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •female gender
- •rigid cystoscopy for the first time
排除标准
- •presence of any contraindication for cystoscopy (such as lidocaine allergy, urinary tract infection, and urethra-related anatomical disorders)
- •any analgesic used 24 hours before cystoscopy
- •manipulations such as Double-J stent placement or removal, and/or bladder biopsy.
研究组 & 干预措施
Video group
The video group watched relaxing video with a ceiling mounted television during the whole cystoscopy.
干预措施: Video group (Other)
Control group
The control group received the standard treatment from a surgical technician who works in the cystoscopy during the whole procedure.The control group didn't watch relaxing video during the procedure.
结局指标
主要结局
change on pain intensity as measured by Visual Analog Scale
时间窗: "5-10 minutes before", "during" and "5 minutes after" cytoscopy.
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("5-10 minutes before" and "5 minutes after" cytoscopy.)
研究者
Elif Gezginci
Principal Investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi