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临床试验/NCT02009553
NCT02009553Unknown不适用

Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
104
试验地点
1
主要终点
State Anxiety Inventory

研究概览

简要总结

Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.

详细描述

Urodynamic study is one of the most common procedures in urological outpatient practice. Patients who wait for the tests may experience significant anxiety.

in this study, patients who are designated to have multichannel Urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. The explanation notes will be sent to the patients in group 1 by mail one month before the test.

Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress immediately before the test. Comparison opf the anxiety level between the two groups will be performed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who will be referred for Urodynamic studies in order to evaluate lower urinary tract symptoms.

排除标准

  • inability to complete the questionnaire due to mental disorders
  • patients who had undergone Urodynamic study previously

结局指标

主要结局

State Anxiety Inventory

时间窗: 10 minutes before the test

Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress. The SAI is a validated questionnaire composed of 20-items measures of anxiety (e.g. ''I am anxious''). Respondents will be requested to rate their endorsement of each item on a four-point scale.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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