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临床试验/NCT02742389
NCT02742389
已完成
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A Telephone Call to Decrease Patient Anxiety Before Urodynamic Testing: a Randomized Controlled Trial

Boston Urogynecology Associates1 个研究点 分布在 1 个国家目标入组 130 人2016年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Urinary Incontinence
发起方
Boston Urogynecology Associates
入组人数
130
试验地点
1
主要终点
Overall pre-procedure anxiety as measured on a visual analog scale.
状态
已完成
最后更新
8年前

概览

简要总结

The purpose of this study is to determine whether an intervention (pre-procedure telephone call by the investigators) will reduce anxiety in women undergoing urodynamic testing (UDT) compared to usual care. Our hypothesis is that women who receive the intervention will report less anxiety immediately before UDT than women who receive usual care.

详细描述

This is a non-blinded, randomized controlled trial. The clinical trial will investigate whether a telephone call by the investigator one week prior to urodynamic testing (UDT) will decrease patient pre-procedure anxiety, improve patient-reported preparedness and increase satisfaction compared to usual care. Patients who are scheduled for UDT will be informed about the study. If the patient agrees to participate in the study, she will be randomized to one of 2 groups based on the week of her scheduled UDT. Group 1: Standard counseling. This group will receive the standard counseling that all Boston Urogynecology Associates (BUA) patients would receive if they are scheduled to have urodynamic testing. This counseling will include a description of the procedure and a handout about urodynamic testing. On the day of their test the participants will be asked to complete a brief survey about their experience before and after their testing. The investigators will also collect some information from their medical record, such as age and prior urogynecologic procedures. Group 2: Standard counseling plus the intervention. The participants assigned to be in the intervention group will receive the standard counseling that all BUA patients who are scheduled for urodynamic testing receive (just like those who are assigned to group 1). This counseling includes a description of the procedure and a handout about urodynamic testing. In addition, the participants will receive a phone call from the investigators 1 week before their testing to talk about the procedure. The investigator calling the participant will document the duration of the phone call and any questions asked by the participant. On the day of their test the participants will be asked to complete the same surveys as group 1. Surveys given to the participants on the day of their UDT appointment will include: 1. A pre-UDT questionnaire that includes questions on demographics, overall anxiety, anxiety about specific elements of procedure, self-reported preparedness and satisfaction. 2. A brief post-UDT questionnaire addressing test experience and pain.

注册库
clinicaltrials.gov
开始日期
2016年4月
结束日期
2017年6月
最后更新
8年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

发起方
Boston Urogynecology Associates
责任方
Principal Investigator
主要研究者

Lekha S. Hota

MD

Boston Urogynecology Associates

入排标准

入选标准

  • 18 years or greater
  • Patients who have decided to schedule Urodynamic Testing to follow-up lower urinary tract dysfunction, pelvic organ prolapse, and/or urinary incontinence

排除标准

  • Presence of indwelling catheters
  • History of prior Urodynamic Testing

结局指标

主要结局

Overall pre-procedure anxiety as measured on a visual analog scale.

时间窗: Day 1

Overall pre-procedure anxiety as measured on a visual analog scale.

研究点 (1)

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