Evaluation of a Wearable Technology to Support Breastfeeding Women (Lactogame)
29 de agosto de 2026 actualizado por: Özlem Ülkü BULUT
Development of a Breast Milk-sensitive Wearable Technology and Evaluation of Its Effects Through the Experiences of Breastfeeding Women
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
36
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ankara
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Ankara, Ankara, Turquía (Türkiye), 06300
- Lokman Hekim University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- 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
- Able to express breast milk for comparison with sensor measurements
- Voluntarily agreeing to participate in the study
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Wearable Breastfeeding Support Technology
Participants will use the wearable prototype and its accompanying mobile application.
Sensor measurements obtained during use will be evaluated and compared with the amount of breast milk obtained through breast pumping.
Participants' experiences with the technology will also be assessed.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Electrical Sensor Signals Obtained From the Wearable Prototype
Periodo de tiempo: During the 15-day intervention period
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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.
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During the 15-day intervention period
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Milk Flow Pattern Parameters Measured by the Wearable Sensor System
Periodo de tiempo: During the 15-day intervention period
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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.
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During the 15-day intervention period
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Expressed Breast Milk Volume Assessed Using the Breast Milk Expression Volume Record Form
Periodo de tiempo: During the 15-day intervention period
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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.
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During the 15-day intervention period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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User Experience and Satisfaction Assessed Using the User Experience and Satisfaction Evaluation Form
Periodo de tiempo: At the end of the 15-day intervention period
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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.
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At the end of the 15-day intervention period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
25 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de agosto de 2026
Publicado por primera vez (Actual)
2 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LactoGameWear01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .