NCT04715893已完成不适用
Ostomy Belt Use Associated Quality of Life
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
- 40
- 试验地点
- 2
- 主要终点
- Change in quality of life as measured by SQOLS
研究概览
简要总结
The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
- •18 - 70 years old
- •Willing and able to sign informed consent
排除标准
- •Patients without stoma or unwilling to wear ostomy belt.
- •Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
研究组 & 干预措施
Ostomy belt group
Experimental
Participants in this group will receive ostomy belts for eight weeks.
干预措施: Ostomy belt (Other)
结局指标
主要结局
Change in quality of life as measured by SQOLS
时间窗: Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use
Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction.
次要结局
未报告次要终点
研究者
Vanessa Hui
Assistant Professor of Clinical Surgery
University of Miami
研究点 (2)
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