An interventional study of AI-Based Oxytocin-Stimulated Smart Lactation Support Vest and Standard Lactation Care and Counseling in Lactation, Lactation Disorder - Postpartum Condition or Complication and Breast Feeding, sponsored by Selcuk University. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Selcuk University · Not applicable, Interventional, and Supportive care
Among 13 studies in Breast Feeding by Selcuk University — 4 open to participants now, 4 under way, none of them phase 3. Breast Feeding · Selcuk University.
Among the 13 studies in Breast Feeding by Selcuk University, this one is the 9th largest by planned enrollment, is the only one that started in 2026, is one of 13 with no phase, and was the 13th registered.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 76 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →4 of the 13 studies in Breast Feeding by Selcuk University 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 50 Years · female · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2026.
Median enrollment 100 across the 13 interventional studies. Of the 9 that completed or were terminated, 0 (0%) have results posted.
Selcuk University is the lead sponsor of 258 studies on the registry; 67 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Breast Feeding by Selcuk University, from their registry updates:
Nothing recorded among them since 2026-09-25.
AI-Based Oxytocin-Stimulated Smart Lactation Support Vest: Development of a Thermo-Massage and Vibration Wearable Vest Design to Support Milk Flow and Prevent Milk Duct Obstruction During Lactation
This randomized controlled trial is the second phase of a three-stage project aimed at developing and clinically evaluating an artificial intelligence (AI)-based oxytocin-stimulated smart lactation support vest with thermo-massage and vibration technologies. The overall project includes prototype development, randomized controlled clinical evaluation, and a qualitative assessment of mothers' experiences with the device.
The randomized controlled trial will evaluate the effectiveness of the AI-based oxytocin-stimulated smart lactation support vest in mothers who have delivered by cesarean section at 32-37 weeks of gestation and whose newborns are hospitalized in the Neonatal Intensive Care Unit (NICU). Because separation of the mother and newborn and the inability to directly breastfeed may interfere with the initiation and maintenance of lactation in this population, the intervention is designed to support milk production and milk flow during the early postpartum period.
The smart lactation support vest is a wearable system incorporating controlled thermo-massage and vibration stimulation. The vest includes heating elements, vibration units, massage and heating components, temperature and bioelectrical impedance sensors, an embedded electronic control system, a rechargeable battery, a control panel, and a mobile application. The system is designed to provide synchronized stimulation to the breast and upper back/scapular region. The breast-area components provide controlled thermal and vibration stimulation, while the back-area massage and heating components are intended to promote relaxation and support the physiological milk ejection reflex. The intervention is designed to support endogenous oxytocin release and facilitate milk flow without administration of exogenous oxytocin.
The AI-based decision-support module integrated into the mobile application will evaluate device-use parameters and user-related information and will provide individualized recommendations regarding the duration and intensity of thermo-massage and vibration stimulation. The system will use information obtained from temperature and bioelectrical impedance sensors together with milk volume, breast fullness, stimulation parameters, duration of use, session frequency, and user feedback. The AI module is intended to function as a supportive decision-support system and will not provide medical diagnosis or treatment decisions. If predefined warning indicators suggesting increased breast temperature and fullness are detected, the system will provide an alert advising the mother to seek evaluation by a healthcare professional.
Eligible participants will be randomly allocated in a 1:1 ratio to either the smart lactation support vest group or the control group. Stratified randomization according to gestational age (32-34 weeks and 35-37 weeks) will be used to promote balance between groups with respect to gestational age.
Participants assigned to the intervention group will use the smart lactation support vest for 10 days, three times daily. Each session will consist of a standardized sequence of 5 minutes of heating, 15 minutes of heating combined with massage, and 10 minutes of heating combined with massage and vibration. During the initial hospitalization period, participants will receive standardized training on how to wear and operate the vest. Following discharge, adherence to the intervention will be monitored through scheduled follow-up, reminder messages, telephone contact, and the mobile application. The first daily session will be supervised by the researcher during the mothers' scheduled visits to the NICU.
Participants in the control group will receive standard lactation care and counseling according to the hospital protocol. Standard care will include routine lactation counseling, guidance regarding breastfeeding and milk expression, breast care, storage of expressed breast milk, daily reminders to express milk, and lactation support when clinically indicated. Both groups will receive the same breast milk expression equipment and breast milk storage materials. The primary difference between the groups will be the use of the smart lactation support vest by participants assigned to the intervention group.
Maternal and newborn outcomes will be monitored for 10 days. The primary outcome is the amount of expressed breast milk, measured in cubic centimeters (cc) per day. Secondary maternal outcomes include oxytocin, prolactin, and cortisol levels; breast fullness; breast temperature; breast discomfort or stinging; lactation-related symptoms; anxiety; and psychological well-being. Hormonal measurements will be obtained at baseline, day 5, and day 10. Breast fullness, breast temperature, and breast discomfort/lactation-related symptoms will be assessed during the 10-day follow-up period using standardized assessment methods.
Newborn outcomes will include daily intake of expressed breast milk, daily weight change, blood glucose levels, and bilirubin levels, which will be monitored and recorded throughout the 10-day follow-up period.
The study will also assess the safety, usability, and acceptability of the wearable system during clinical use. Device-related observations, user feedback, and adherence to the intervention will be recorded. Mothers assigned to the intervention group will complete a user experience and satisfaction assessment at the end of the 10-day intervention period.
The study is designed to determine whether use of the AI-based oxytocin-stimulated smart lactation support vest, in addition to standard lactation care, improves expressed breast milk production and selected maternal and newborn outcomes compared with standard lactation care alone.
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.
For Mothers:
For Newborns:
Exclusion Criteria:
For Mothers:
For Newborns:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the intervention group will use the AI-based oxytocin-stimulated smart lactation support vest for 10 days, three times daily, in addition to standard lactation care and counseling. Each session will consist of 5 minutes of heating, 15 minutes of heating combined with massage, and 10 minutes of heating combined with massage and vibration. The wearable system is designed to provide controlled thermo-massage and vibration stimulation to support milk flow and lactation during the early postpartum period.
Device: AI-Based Oxytocin-Stimulated Smart Lactation Support Vest
Participants assigned to the control group will receive standard lactation care and counseling according to the hospital protocol. Standard care will include routine lactation counseling, guidance regarding breastfeeding and milk expression, breast care, storage of expressed breast milk, daily reminders to express milk, and lactation support when clinically indicated.
Device: AI-Based Oxytocin-Stimulated Smart Lactation Support Vest · Behavioral: Standard Lactation Care and Counseling
Participants assigned to the intervention group will use the AI-based oxytocin-stimulated smart lactation support vest for 10 days, three times daily, in addition to standard lactation care and counseling. Each session will consist of 5 minutes of heating, 15 minutes of heating combined with massage, and 10 minutes of heating combined with massage and vibration. The wearable vest is designed to provide controlled thermo-massage and vibration stimulation to support milk flow and lactation during the early postpartum period. The system includes temperature and bioelectrical impedance sensors and an AI-based decision-support module intended to provide individualized recommendations regarding stimulation parameters.
Participants assigned to the control group will receive standard lactation care and counseling according to the hospital protocol. Standard care will include routine lactation counseling, guidance regarding breastfeeding and milk expression, breast care, storage of expressed breast milk, daily reminders to express milk, and lactation support when clinically indicated.
Daily Expressed Breast Milk Volume (mL/day)
The amount of breast milk expressed by the mother per day, measured in milliliters (mL/day) during the 10-day follow-up period.
Time frame: Baseline (Day 0) through Day 10 postpartum
Maternal Serum Oxytocin Level (pg/mL)
Maternal serum oxytocin concentration measured using laboratory analysis.
Time frame: Baseline, Day 5, and Day 10
Maternal Serum Prolactin Level (ng/mL)
Maternal serum prolactin concentration measured using laboratory analysis.
Time frame: Baseline, Day 5, and Day 10
Maternal Serum Cortisol Level (µg/dL)
Maternal serum cortisol concentration measured using laboratory analysis.
Time frame: Baseline, Day 5, and Day 10
Breast Fullness
Breast fullness assessed using the Breast Fullness Assessment Scale. The scale consists of one item scored from 1 to 6, with higher scores indicating greater breast fullness and sensitivity.
Time frame: Day 1 through Day 10
Lactation Onset Symptoms
Maternal perception of lactation onset symptoms, including increased breast temperature and breast stinging, assessed using a Visual Analog Scale ranging from 0 (no symptom) to 10 (most intense symptom). Higher scores indicate greater symptom intensity. Unit of Measure: VAS score (0-10)
Time frame: Day 1 through Day 10
Daily Newborn Expressed Breast Milk Intake (mL/day)
Change in newborn body weight measured in grams during the study period.Unit of Measure: g/day
Time frame: Day 1 through Day 10
Newborn Blood Glucose Level (mg/dL)
Newborn blood glucose level recorded as part of clinical follow-up.Unit of Measure: mg/dL
Time frame: Day 1 through Day 10
Newborn Bilirubin Level (mg/dL)
Newborn bilirubin level recorded as part of clinical follow-up.Unit of Measure: mg/dL
Time frame: Day 1 through Day 10
Maternal Well-Being
Maternal psychological well-being assessed using the WHO-5 Well-Being Index. The index consists of five items scored from 0 to 5, with a total raw score ranging from 0 to 25. Higher scores indicate better well-being.WHO-5 score (0-25)
Time frame: Baseline and Day 10
Postpartum-Specific Anxiety
Postpartum-specific anxiety assessed using the Postpartum Specific Anxiety Scale (PSAS), a 47-item self-report instrument scored on a 4-point Likert scale. Higher scores indicate greater postpartum-specific anxiety.Unit of Measure: PSAS score
Time frame: Baseline and Day 10
No study locations are listed for this record.
Plan to share: No — Individual participant-level data (IPD) will not be shared with other researchers because the dataset contains potentially sensitive maternal and newborn health information. Data will be retained and managed by the research team in accordance with applicable ethical, institutional, and data protection requirements. De-identified aggregate findings will be reported in scientific publications and presentations.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 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 12 months is close to 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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