Effects of Mindfulness Meditation on Patients' Satisfaction During Urodynamic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Satisfaction during the urodynamic study testing
研究概览
简要总结
The purpose of this investigator-initiated study is to evaluate if mindfulness-based stress reduction (MBSR) will improve satisfaction and reduce anxiety during a urodynamic study (UDS).
详细描述
Urodynamic studies (UDS) are used to measure the functionality of the bladder and urethra to be able to evaluate lower urinary tract symptoms (LUTS). UDS consists of catheterization, uroflow and cystometrogram. Intravesical, vaginal or rectal transducer placements, and placement of perineal electrodes are part of the study protocol. During the study the bladder will be filled slowly with sterile fluid and the patient will be asked about sensation of filling. At the end of the study the patient will be asked to void.
Although beneficial for diagnosis of underlying LUTS, UDS maybe associated with heightened patient anxiety and feeling of discomfort. In a recently published pilot study, it was shown that a mindfulness-based stress reduction (MBSR) protocol may help improve a patient's emotional health and perception of UDS. To validate the findings from this previous study, the current study aims to implement a MBSR protocol in a randomized prospective study. Patients scheduled for UDS will be randomized into two groups. One group will listen to mindfulness meditation prior to the UDS and the other group won't.
All patients will complete validated questionnaires to assess their satisfaction, anxiety and pain level as well as lower urinary tract symptoms before and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male patients between ages 18 and 99 with clinical indication for UDS ordered by treating physician
排除标准
- •None English speakers will be recruited for this study.
- •Pregnancy
研究组 & 干预措施
Application of mindfulness meditation prior to UDS
Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.
干预措施: Mindfulness meditation (Behavioral)
No meditation prior to UDS
The control group will be seated in a quiet empty room where they wait for 10 min.
干预措施: Mindfulness meditation (Behavioral)
结局指标
主要结局
Satisfaction during the urodynamic study testing
时间窗: 1 year
Likert scale will measure satisfaction with urodynamics in both groups. The scale ranges are: very dissatisfied=0, dissatisfied=1, somehow satisfied=2, satisfied=3, very satisfied=4), with 0 as the worse outcome.
次要结局
- Self evaluation of anxiety and comfort level(1 year)
- Pain level(1 year)
