Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: 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
- 27
- 主要终点
- Anxiety during urodynamics as measured the STAI-6.
研究概览
简要总结
In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?
详细描述
The subjects are being asked to consider participation in this research study. The purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS) results in less pain, anxiety and discomfort.
The participants will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise participants will be asked to focus attention on breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes in which participants will not be asked to engage in any physical activity other than sitting and breathing. The participants will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation.
After the participants UDS evaluation, questions will be asked about the urodynamic procedure. The participants will be asked to answer questions on a UDS and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of urinary symptoms requiring urodynamic testing
- •Stress incontinence
- •Mixed incontinence
- •Urge incontinence
- •Overactive bladder
- •Urinary retention
- •Lower urinary tract symptoms
- •Are Department of Defense (DoD) beneficiaries
排除标准
- •Neurogenic bladder
- •Interstitial cystitis
- •Chronic bladder pain
- •Inability to have urodynamics performed
- •Are Not DoD beneficiaries
- •Lack capacity to consent
研究组 & 干预措施
Mindfullness exercises
Participate in mindfulness exercises prior to urodynamic studies (UDS). As a participant, you will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise you will be asked to focus your attention on your breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes.
干预措施: Mindfulness exercises (Behavioral)
Control
Sitting quietly in a room alone.
结局指标
主要结局
Anxiety during urodynamics as measured the STAI-6.
时间窗: Day 1
The STAI-6, State Trait Anxiety Inventory, is a validated questionnaire that measures anxiety. The total score from the STAI-6 will be used with a range of score from 4-24. Higher scores indicate higher level of anxiety.
次要结局
- Pain as measured by the VAS(Day 1)
- Positive and negative emotions as measured by the urodynamic questionnaire(Day 1)
研究者
Forrest Jellison
Principle Investigator
San Antonio Uniformed Services Health Education Consortium