An interventional study of Breast Milk-Sensitive Wearable Technology in Breastfeeding, sponsored by Özlem Ülkü BULUT. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Özlem Ülkü BULUT · Not applicable, Interventional, and Other
Among 274 studies in Breast Feeding with a site in Turkey — 68 open to participants now, 77 under way, none of them phase 3. Breast Feeding · Turkey.
Among the 274 studies in Breast Feeding with a site in Turkey, this one is the 244th largest by planned enrollment of the 252 interventional ones, is one of 33 that started in 2026, is one of 251 with no phase, reaches primary completion later than 59 of the 76 other live ones, and was the 267th registered.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 36 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →68 of the 274 studies in Breast Feeding with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 126 Breast Feeding studies recruiting now, 66 (52%) set no upper age limit and 58 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 18 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →274 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 33 started in 2026.
Median enrollment 80 across the 252 interventional studies, 163 across the 22 observational. Of the 178 that completed or were terminated, 0 (0%) have results posted.
None of the 274 has an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Özlem Ülkü BULUT as lead sponsor.
Özlem Ülkü BULUT has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
19 of the studies in Breast Feeding with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07902271Kutahya Health Sciences UniversityThe Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels | 2026-11-15 |
| NCT07656207Gaziantep Islam Science and Technology UniversityThe Effect of Skin-to-skin Contact at Birth | 2026-12 |
| NCT07800078Özlem Ülkü BULUTEvaluation of a Wearable Technology to Support Breastfeeding Women | 2026-12-01 |
| NCT07864753Balikesir UniversityEVALUATION OF TWO MIDWIFE-SUPPORTED BREASTFEEDING POSITIONS DURING THE FIRST BREASTFEEDING FOLLOWING VAGINAL BIRTH | 2026-12-30 |
| NCT07899593Karadeniz Technical UniversityEffect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers | 2026-12-31 |
Among the 274 studies in Breast Feeding with a site in Turkey, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Breast Milk-Sensitive Wearable Technology
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.
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.
Time frame: At the end of the 15-day intervention period
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 2 months is below that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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