Health TrialsbyHealthPanel

Evaluation of a Wearable Technology to Support Breastfeeding Women

ConditionBreastfeeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorÖzlem Ülkü BULUT

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged 18-45 years

Currently breastfeeding

Having an infant aged 0-6 months

Willing to use the wearable technology and accompanying mobile application for 15 days

Disqualifiers

Having a medical condition that prevents breastfeeding or breast milk expression

Having an active breast or nipple condition that prevents the use of the wearable prototype

Being unable to use the wearable technology or mobile application during the study period

Withdrawing consent at any stage of the study

Trial design

Design model

Single group

Treatments tested in this trial

  • Breast Milk-Sensitive Wearable Technology

    Device

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Wearable Breastfeeding Support TechnologyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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.

Time frame
At the end of the 15-day intervention period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Özlem Ülkü BULUT

Lead sponsor

Lokman Hekim University

Sponsor institution

Lokman Hekim University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: