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

Not Applicable

Completed

• Conditions: Lactation
• Interventions: Device: BrownieForSymphony use

• Registration Number: NCT02496429
• Lead Sponsor: Medela AG

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BrownieForSymphony use	BrownieForSymphony use	Each participant will use the BrownieForSymphony pumpset

Primary Outcome Measures

Name	Time	Method
Usability Scale (SUS) Symphony Pumpset usability	day at inclusion	Rating of the Usability of the Symphony Pumpset
Usability Scale (SUS) BrownieForSymphony Pumpset usability	after 5 days	Rating of the Usability of the BrownieForSymphony Pumpset

Trial Locations

Locations (2)

University Tuebingen; 🇩🇪 Tuebingen, Germany

Klinik Dr. Geißenhofer; 🇩🇪 Munich, Germany