This study aims to evaluate a wearable technology developed to support breastfeeding women. The study will assess the performance of sensors in the wearable prototype for monitoring breast milk fullness and milk flow and compare the sensor measurements with the amount of breast milk obtained through breast pumping. The study will also evaluate women's experiences, satisfaction, perceived usefulness, and ease of use of the wearable prototype and its mobile application. The technology is intended for monitoring and support purposes and will not be used for diagnosis, treatment, or clinical decision-making.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
Participants will use a breast milk-sensitive wearable prototype integrated with a mobile application. The wearable technology collects sensor-based measurements related to breast milk fullness and milk flow. Sensor measurements will be compared with the amount of breast milk obtained through breast pumping. Participants' experiences, satisfaction, perceived usefulness, and ease of use of the wearable technology and mobile application will also be evaluated.
Lokman Hekim University
Ankara, Ankara, Turkey (Türkiye)
Electrical Sensor Signals Obtained From the Wearable Prototype
The wearable sensor system will acquire and analyze sensor signals to generate a Breast Milk Fullness Index ranging from 0 to 100. Higher values indicate greater estimated breast milk fullness. Measurements will be obtained in relation to breastfeeding and/or breast pumping sessions and compared with reference measurements of milk removal.
Time frame: During the 15-day intervention period
Milk Flow Pattern Parameters Measured by the Wearable Sensor System
Milk flow-related signal patterns will be acquired and analyzed by the LactoGame wearable sensor system during breastfeeding and/or breast pumping. Quantitative system-derived parameters, including average and peak signal characteristics, will be used to characterize milk flow patterns.
Time frame: During the 15-day intervention period
Expressed Breast Milk Volume Assessed Using the Breast Milk Expression Volume Record Form
Expressed breast milk volume will be recorded using the Breast Milk Expression Volume Record Form. For each pumping session, the amount of breast milk obtained will be recorded in milliliters (mL), together with breast side, expression method, and expression duration. Expressed milk volume will be used as a reference measurement for comparison with sensor-derived measurements.
Time frame: During the 15-day intervention period
User Experience and Satisfaction Assessed Using the User Experience and Satisfaction Evaluation Form
User experience and satisfaction will be assessed using the researcher-developed 14-item User Experience and Satisfaction Evaluation Form. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 14 to 70, with higher scores indicating a more positive user experience and greater satisfaction with the wearable prototype and mobile application. The form also includes three open-ended questions to obtain additional qualitative feedback.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At the end of the 15-day intervention period