Interventions to Decrease Anxiety in Patients Undergoing Urodynamic Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
This is a randomized controlled trial to determine if music, a video, or standard of care will decrease anxiety in patients undergoing urodynamic testing.
详细描述
Research Design and Methods
This study was a randomized controlled trial assessing the interventions of music, a patient educational video, or usual care pre-test teaching practice and anxiety before patients undergo urodynamic testing. This study enrolled women who were scheduled to undergo urodynamic testing within the Female Pelvic Medicine and Reconstructive Surgery clinic on main campus and at Fairview Hospital. Consenting participants were randomized to receive either usual practice pre-test teaching, usual practice pre-test teaching with soothing music in the background and throughout the test, or usual practice pre-test teaching and watching an educational video before the test was performed. The participants filled out a short questionnaire before urodynamic testing was started with two VAS scales assessing anxiety and pain and Likert Scale Questions, a second short questionnaire when the patient feels "strong urge" with two VAS scales assessing anxiety and pain, and a third questionnaire once the patient has completed the test again testing VAS anxiety and pain as well as some Likert scale questions.
The primary outcome was to determine if pre-urodynamic testing anxiety was decreased after watching a pre-test educational video, or by listening to music before and throughout the procedure, or by receiving standard of care pre-test teaching. Secondary outcomes were to determine baseline anxiety in our urodynamic patient population and to determine if there is decreased discomfort due to the intervention as well as to evaluate if there were certain patients that would benefit from increased information.
Enrollment All patients undergoing urodynamic testing for the first time who are over the age of 18 years old, female with presentation for urodynamics for urinary dysfunction, urinary incontinence, prolapse, or presurgical evaluation of voiding function were screened for participation in the study.
Exclusion criteria included:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years old and above,
- •urinary dysfunction
- •urinary incontinence
- •presurgical evaluation of voiding function
- •Never undergone Urodynamics before
排除标准
- •Pregnancy
- •Ongoing urinary tract infections
- •Inability to cooperate
- •Inability to give consent
- •Non-English speakers
- •Patients who have undergone urodynamic testing in the past
研究组 & 干预措施
Standard of Care
Patient underwent urodynamic testing by receiving only standard of care with mailed information and during test teaching.
干预措施: Standard of care (Other)
Music
Patient underwent urodynamic testing while listening to music that was 60 beats per minute and received standard of care information and teaching.
干预措施: Music (Behavioral)
Video
Patient watched an informational video prior to urodynamic testing.
干预措施: Video (Behavioral)
结局指标
主要结局
Anxiety
时间窗: One day
The primary outcome is to determine if pre-urodynamic testing anxiety is decreased after watching a pre-test educational video, or by listening to music before and throughout the procedure, or by receiving standard of care pre-test teaching. For measurement of anxiety we used 100mm Visual analog scales. We used a questionnaire to obtain demographics. We used a five point Likert scale to ask questions about their use of the internet and information seeking behavior.
次要结局
- Discomfort(One Day)