跳至主要内容
临床试验/NCT02496429
NCT02496429已完成不适用

ESP Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set

Medela AG2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Medela AG
入组人数
25
试验地点
2
主要终点
Usability Scale (SUS) Symphony Pumpset usability

研究概览

简要总结

The primary objectives of this study is to evaluate how professionals rate the reliability and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump set

4.2 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 first impression of lactating woman regarding pumping with the BrownieForSymphony pump set

详细描述

This is a 5 day case study to evaluate the reliability and usability of the BrownieForSymphony pump set.

The study consists of two different participant groups, professionals (e.g. lactation consultants, nurses) and lactating women.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Hospitalized lactating woman >18 years which are pumping breast milk

排除标准

  • •hospitalized lactating woman has a medical indication for pumping (e.g. Mastitis, cracked nipples) lactating woman used a breast shield size >27 and <24

研究组 & 干预措施

BrownieForSymphony use

Other

Each participant will use the BrownieForSymphony pumpset

干预措施: BrownieForSymphony use (Device)

结局指标

主要结局

Usability Scale (SUS) Symphony Pumpset usability

时间窗: day at inclusion

Rating of the Usability of the Symphony Pumpset

Usability Scale (SUS) BrownieForSymphony Pumpset usability

时间窗: after 5 days

Rating of the Usability of the BrownieForSymphony Pumpset

次要结局

未报告次要终点

研究者

发起方
Medela AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Evaluation of the Reliability and Usability of the... | 临床试验