AI-Based Oxytocin-Stimulated Smart Lactation Support Vest

NCT07765992 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-08-14

No results posted yet for this study

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

Interventions

DEVICE

AI-Based Oxytocin-Stimulated Smart Lactation Support Vest

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.

BEHAVIORAL

Standard Lactation Care and Counseling

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.

Sponsors & Collaborators

  • Selcuk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2027-12-01
Completion
2028-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765992 on ClinicalTrials.gov