Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use

Medela AG22 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Lactation

Interventions

Pumping CE-marked Symphony Pumpset

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * o Woman has a medical condition of the breast (eg. Mastitis)

Outcomes

Primary Outcomes

Usability Scale (SUS) Symphony Pumpset usability

Rating of the Usability of the Symphony Pumpset

Time frame: after 7 days

Usability Scale (SUS) BrownieForSymphony Pumpset usability

Rating of the Usability of the Symphony Pumpset

Time frame: after 14 days

Secondary Outcomes

User experience questionnaire (UEQ)

Time frame: after 7 days, 14 days, 3 week