ESP II Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medela AG
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Usability Scale (SUS) BrownieForSymphony Pumpset usability
研究概览
简要总结
The overall purpose of this study is to evaluate the reliability and usability of the reusable BrownieForSymphony pump set in home use.
The primary objectives of this study is to asses and compare the System Usability Scale (SUS) score of the BrownieForSymphony pump set and the current used Symphony pump set.
Secondary Objectives
The secondary objectives of this study are:
to evaluate the rate of usability problems with the BrownieForSymphony pump set
- to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump set
- to evaluate perceived comfort during pumping with the BrownieForSymphony pump set Prospective Cohort Study (quasi Cross over design)
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Lactating woman >18 years who
- •Have been pumping for at least 7 days with the Symphony pump and pump set prior to study participation
- •Have been pumping at least 10 times in the week prior to study participation
- •Consistently pump 10 ml of milk or more per breast, per pumping session prior to study participation
- •Currently use a breast shield size of 24 mm
- •Participant has agreed to pump at least 10 times a week over the next three weeks
排除标准
- •o Woman has a medical condition of the breast (eg. Mastitis)
研究组 & 干预措施
Pumping
Each particpant will pump with the current pumpset one week and then two weeks with the pumpset
干预措施: Pumping CE-marked Symphony Pumpset (Device)
Pumping
Each particpant will pump with the current pumpset one week and then two weeks with the pumpset
干预措施: Pumping BrownieForSymphony Pumpset (Device)
结局指标
主要结局
Usability Scale (SUS) BrownieForSymphony Pumpset usability
时间窗: after 14 days
Rating of the Usability of the Symphony Pumpset
Usability Scale (SUS) Symphony Pumpset usability
时间窗: after 7 days
Rating of the Usability of the Symphony Pumpset
次要结局
- User experience questionnaire (UEQ)(after 7 days, 14 days, 3 week)