Self-Catheterization Mirror System for Female Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- System Usability Scale
研究概览
简要总结
The purpose of this study is to test a modified mirror system for female patients to use during self-catheterization.
详细描述
Many female patients have difficulties with self-catheterization. Mirrors currently used for this procedure have limited stability and visibility to easily view the urethral opening during catheterization, particularly for individuals with motor impairments. This can be especially frustrating because catheterization is performed frequently throughout the day and may need to occur at home or in public facilities.
The purpose of this study is to test the usability and efficacy of a modified self-catheterization mirror system for female patients. The modified self-catheterization mirror system makes adjustments to a standard, hospital-provided cathing mirror to help female patients with a range of motor abilities catheterize themselves in various postures and settings. Namely, the system offers (1) an alternative way to hold the mirror, by suspending it between the legs rather than attaching it to the toilet, and (2) lights that can be turned on for improved visibility during the self-catheterization process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females age 13 or older
- •Urinary retention related to spinal cord injury or other medical conditions resulting in need for catheterization
- •Individuals with sufficient upper limb function to catheterize independently or with minimal assistance, or as deemed appropriate for the study by the Principle Investigator.
排除标准
- •Individuals younger than 13 years old
- •Individuals with cognitive deficits or visual impairments that may impact safe use of the devices used
- •Severe Range of Motion restrictions of the upper and/or lower extremities
研究组 & 干预措施
Modified Self-Catheterization Mirror
Following training, participants will have a modified mirror for self-catheterization. They will record the mirror used, position, and time for self-catheterization. They will also complete the System Usability Scale for each mirror related to self-operation and user satisfaction.
干预措施: Modified Self-Catheterization Mirror (Device)
Standard Self-Catheterization Mirror
Following training, participants will have a standard, hospital-provided mirror for self-catheterization. They will record the mirror used, position, and time for self-catheterization. They will also complete the System Usability Scale for each mirror related to self-operation and user satisfaction.
干预措施: Standard Self-Catheterization Mirror (Device)
结局指标
主要结局
System Usability Scale
时间窗: This assessment was only completed once at the end of each arm within 3 days prior to inpatient discharge.
Patient-reported usability and experience when using the mirror, with scores ranging from -20 to +20 (higher scores indicating higher usability performance). This assessment included 10 items with statements that participants scored on a Likert scale from strongly disagree (-2) to strongly agree (+2).
次要结局
- Time to Self-Cath(1-7 days)
- Time to Self-Cath(1-7 days)
研究者
Megan O'Brien
Principal Investigator
Shirley Ryan AbilityLab