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临床试验/NCT04446143
NCT04446143已完成不适用

Effects of Mindfulness Meditation on Patients' Satisfaction During Urodynamic Study.

Loma Linda University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

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

Other

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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