Use of Diaphragmatic Breathing (DB) in the Management of Bladder and Bowel Disorders in Children: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).
研究概览
简要总结
Urination is a result of a complex neuro-muscular coordination which involves the action and arrangement of different parts of nervous systems as well as the muscular structure of the lower part of the urinary system. When there is an abnormal pattern in bladder and bowel habits without any known neuronal lesions, the condition is called bladder and bowel disorder (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary accidents to urinating much less than expected during the day.
The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a beneficial basic and harmless form of treatment widely used for all children with BBD. SU involves explaining of the problem to the children and their parents by the doctors and educating them on proper voiding mechanisms, sitting, and standing positions as well as how and when to void.
The purpose of this study is to explore the possibility of testing the additive effectiveness of Diaphragmatic Breathing exercise (DB) as an alternative and harmless additional treatment to SU in children with BBD.
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
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with bladder and bowel disorders (BBD) will be diagnosed by the attending pediatric urologists via a combination of thorough clinical history, physical examination, BBD Questionnaire, uroflowmetric evaluation, and voiding and stool diary.
排除标准
- •Known anatomic or neurological lower urinary tract abnormalities such as posterior urethral valve, urethral obstruction or stricture, ectopic ureters, congenital abnormalities of the spinal cord, or any previous surgery of the lower urinary tract.
- •Current use of medication or treatments which affects bladder or ANS function. These include anti-cholinergics, anti-psychotics, anti-depressants, and neuromodulators.
- •Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
- •Serious pulmonary issues or diaphragmatic problems that would interfere with the practice of diaphragmatic breathing technique.
- •Psychological/behavioral abnormalities severe enough to prevent the cooperation of the child with the study coordinator or the urologist.
- •Inability to provide consent.
- •Inability to speak and/or understand in English.
结局指标
主要结局
Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).
时间窗: 3 months
次要结局
- Change in average urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Treatment acceptability of the proposed intervention (diaphragmatic breathing).(3 months)
- Change in Total Power from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Change in peak urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Change in post-void residual volume from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Number of withdrawals during the treatment period.(3 months)
- Change in BBD score from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Number of children adhering to the diaphragmatic breathing schedule that is given to them.(3 months)
- Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Change in heart rate from baseline to end of treatment period for both study groups.(Baseline and 3 months)
- Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups.(Baseline and 3 months)
研究者
Kourosh Afshar
Study Principal Investigator
University of British Columbia