Development and Psychometric Validation of a Scale Assessing "the Acceptance" of Clean Intermittent Self Catheterization in a Neurological and no Neurological Population With Indication to Self Catheterization.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intermittent catheterization acceptance test (I-CAT)
研究概览
简要总结
The aim of the study is to create and validate a specific test named Intermittent Catheterization Acceptance Test (I-CAT), assessing "the acceptance" of clean intermittent self catheterization (CISC) in a neurological and no neurological population with indication to self catheterization.
CISC avoids urological complications in bladder with chronic and improves quality of life. Despite theses challenges, the learning of CISC can face some physical, cognitive and psychological difficulties. Recently, we have validate a new test for predicting the physical and cognitive abilities to practice CISC named "PP-Test". Meanwhile, psychological factors are not explored in this test. To our knowledge, no study has been conducted in order to demonstrate in a prospective trial, which kind of psychological barriers can exist. Likewise it would be interesting to create a new test assessing the psychological "acceptance" of the patients to CISC before learning (I-CAT). Based on the results of this self-assessment test, the specific nurse could then change her speech by playing down the importance of some fear and anxiety described by the patients. The learning of CISC would be facilitated.
详细描述
The first version of the questionnaire (I-CAT) has already been elaborated from some neuro-urology experts and patients's comments.
The final version will be validated after a feasibility study. The psychometric criteria will be validated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with neurological disease (brain, trauma and no trauma spinal injury, cauda equine syndrome) or non neurological disease
- •Patients seen in consultation or in traditional hospital
- •Indication for the realization of self-catheterization Intermittent must be asked because of a bladder-type retentionist or overactive bladder with an indication of medical (anticholinergics or botulinum toxin intra-detrusor injection) or surgical (kind of expansion enterocystoplasty) treatment to prevent bladder emptying without urinary catheterization
- •PP-Test score ≥10/15
- •Age > 18 years
- •Patient with social security
排除标准
- •Urethral injury preventing the practice of self-catheterization
- •Indication to installing a suprapubic catheter or probe
- •Patients able to answer to questionnaire and communicate in French
研究组 & 干预措施
Cohort
Patients with dysvoiding function and chronic urinary retention, with an indication to CISC.
干预措施: Intermittent catheterization test (Behavioral)
结局指标
主要结局
Intermittent catheterization acceptance test (I-CAT)
时间窗: 2 years
In order to validate the questionnaire, the patients will have to respond to I-CAT at 3 times: * the day the CISC's indication is decided * at the learning'CISC consultation about 8 days later * during the verification's CISC consultation about 15 days later
次要结局
未报告次要终点