RecruitingNot Applicable

The Relationship Between Oxytocin Massage in Mothers With Insufficient Milk Production in the Early Postpartum Period and Breastfeeding Self-Efficacy and Milk Let-down Reflex: A Randomized Controlled Study

Turkey (Türkiye)128 participantsStarted 2026-05-12

Plain-language summary

This randomized controlled trial aims to evaluate the effects of oxytocin massage on breastfeeding self-efficacy and the milk ejection reflex among mothers experiencing insufficient milk supply in the early postpartum period. Insufficient milk supply is a common issue often linked to maternal stress, which can inhibit oxytocin release and negatively impact the milk ejection reflex and the mother's confidence in breastfeeding. By applying oxytocin massage to the thoracic paravertebral region, this study seeks to stimulate oxytocin release non-pharmacologically. The primary objective is to determine whether this intervention improves physiological milk flow and enhances maternal breastfeeding self-efficacy compared to routine postpartum care.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Being 18 years of age or older * Being in the early postpartum period (within the first 24-48 hours after birth) * Having had a single, live birth via vaginal delivery or cesarean section * Having a term (≥37 weeks) and healthy baby * Being in the same room as the baby (rooming-in practice) * Having started breastfeeding * Reporting insufficient milk production or expressing difficulty with the milk let-down reflex * Not having a cognitive, neurological, or serious psychiatric problem that would impede communication * Voluntary participation in the study and providing written informed consent Exclusion Criteria: * Having given birth preterm (\<37 weeks) * Having given birth as a result of a multiple pregnancy * Having been admitted to the neonatal intensive care unit (NICU) * The baby having a congenital anomaly that prevents breastfeeding (e.g., cleft lip and palate) * The mother having medical conditions that contraindicate breastfeeding (HIV infection, active tuberculosis, etc.) * The mother developing serious postpartum complications (postpartum hemorrhage, eclampsia, serious infection, etc.) * The presence of anatomical or pathological conditions related to the breast that may prevent breastfeeding (advanced mastitis, breast abscess, etc.) * The presence of skin lesions, surgical incisions, or infections in the back that would prevent the application of oxytocin massage * Failure to complete the intervention or wishing to withdraw from the study …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1My baby's doctor mentioned I may have low milk supply — could oxytocin massage be something worth trying in my situation, and would this trial be appropriate to discuss with my care team?
2This trial is measuring breastfeeding self-efficacy using a specific scale — can you help me understand what that means in practice, and whether feeling more confident about breastfeeding is something this kind of massage could realistically support?
3Since this is listed as a non-phase study focused on a hands-on massage technique, what do we already know about the safety of oxytocin massage in the early postpartum period, and are there any situations where it might not be recommended?
4The trial involves a specific massage technique aimed at stimulating the milk let-down reflex — is this something a lactation consultant could show me how to do, and how does it compare to other approaches my care team might already suggest for low milk supply?
5If I don't end up joining this trial, are there other evidence-based options for improving milk production in the early weeks postpartum that we should be considering alongside or instead of this approach?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Breastfeeding Self-Efficacy Scale-Short Form

Timeframe: Baseline (immediately before the intervention) and immediately after the single 20-30 minute session of oxytocin massage.

Trial details

NCT IDNCT07609693

SponsorTokat Gaziosmanpasa University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-12

Contact for this trial

Emine AKSÜT AKÇAY, Assistant Professor

(344) 300- 2654 emineaksutakcay@ksu.edu.tr/

View on ClinicalTrials.gov More Lactation Disorders trials