AI-Based Oxytocin-Stimulated Smart Lactation Support Vest

NCT07765992 | Not Yet Recruiting

• 1 other identifier: 2026/483
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lactation; Lactation Disorder - Postpartum Condition or Complication; Breast Feeding

Keywords

Lactation; Breast Milk Production; Wearable Technology; Thermo-Massage; Vibration Therapy; Artificial Intelligence; Smart Wearable Device; Cesarean Section; Neonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0) through Day 10 postpartum

Secondary Outcomes (10)

• Maternal Serum Oxytocin Level (pg/mL)

  Baseline, Day 5, and Day 10

• Maternal Serum Prolactin Level (ng/mL)

  Baseline, Day 5, and Day 10

• Maternal Serum Cortisol Level (µg/dL)

  Baseline, Day 5, and Day 10

• Breast Fullness

  Day 1 through Day 10

• Lactation Onset Symptoms

  Day 1 through Day 10

Study Arms (2)

Arm 1 - Intervention

EXPERIMENTAL

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

Arm 2 - Control

ACTIVE COMPARATOR

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

Interventions

AI-Based Oxytocin-Stimulated Smart Lactation Support Vest DEVICE

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.

Arm 1 - Intervention; Arm 2 - Control

Standard Lactation Care and Counseling BEHAVIORAL

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.

Arm 2 - Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Individuals who self-identify as female and meet all other study eligibility criteria are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For Mothers:
• Aged 18 years or older;
• Primiparous;
• Delivered by cesarean section;
• Singleton pregnancy;
• Delivered at 32-37 weeks of gestation;
• Newborn admitted to the Neonatal Intensive Care Unit (NICU);
• No medical condition that would prevent breast milk expression or use of the smart lactation support vest;
• Owns or has access to a smartphone;
• Willing to participate voluntarily and able to provide written informed consent;
• Able to read, understand, and communicate in Turkish.
• For Newborns:
• Born at 32-37 weeks of gestation;
• No condition that would prevent the intake of breast milk.

You may not qualify if:

• For Mothers:
• Body mass index (BMI) \>30 kg/m²;
• History of a psychiatric diagnosis or currently receiving psychiatric treatment (e.g., depression, schizophrenia, obsessive-compulsive disorder);
• Any medical condition that may interfere with breast milk expression (e.g., mastitis);
• Stillbirth;
• History of thyroid dysfunction;
• Any physical condition or disability that prevents wearing the smart lactation support vest;
• Previous breast surgery (e.g., breast implant surgery, mastectomy);
• Insufficient Turkish language proficiency preventing the participant from understanding and completing the study instruments.
• For Newborns:
• Cleft palate or cleft lip;
• Congenital anomaly;
• Requirement for mechanical ventilation.

Sponsors & Collaborators

• Selcuk University: lead

MeSH Terms

Conditions

Breast Feeding

Interventions

Counseling

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Seyhan Çankaya, PhD

CONTACT

+903322233577; seyhane32@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share