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

NCT07609693 | Recruiting DMC

• 1 other identifier: 2026/11 -08
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lactation Disorders

Keywords

Lactation Disorders; Breast Feeding; Postpartum Period

Outcome Measures

Primary Outcomes (1)

• Breastfeeding Self-Efficacy Scale-Short Form

  Breastfeeding self-efficacy was assessed using the 14-item Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). It is a 5-point Likert-type scale (1 = "not at all confident" to 5 = "always confident"). The total score ranges from 14 to 70. Higher scores indicate a higher level of breastfeeding self-efficacy.

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

Secondary Outcomes (1)

• Perception of Insufficient Milk Supply Questionnaire

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

Study Arms (2)

Oxytocin Massage Group

EXPERIMENTAL

Mothers assigned to this group will receive a single session of oxytocin massage prior to breastfeeding. The massage will be applied by the researcher to the thoracic paravertebral region (T4-T6 level) using rhythmic and circular movements for 20-30 minutes, in accordance with a standardized protocol.

Other: Oxytocin Massage

Routine Care Group

NO INTERVENTION

Mothers assigned to this group will not receive any additional experimental interventions. They will only receive the institution's routine standard postpartum hospital care.

Interventions

Oxytocin Massage OTHER

Oxytocin massage was applied to the mothers assigned to the experimental group as a non-pharmacological intervention. According to the standardized intervention protocol, a single session of oxytocin massage, lasting for 20 to 30 minutes in total, was performed on the thoracic and scapular regions of the back. The massage was administered by the researcher using rhythmic and circular movements focusing on the paravertebral area to stimulate afferent nerve pathways and promote endogenous oxytocin release. This aimed to facilitate the milk ejection reflex and support breastfeeding self-efficacy in the early postpartum period.

Oxytocin Massage Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participation is restricted to biological females because the study specifically investigates maternal physiological processes related to the early postpartum period, lactation, the milk ejection reflex, and breastfeeding.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 will be excluded.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University Hospital, Department of Obstetrics and Gynecology, Delivery Room

Kahramanmaraş, Merkez, 46100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lactation Disorders; Breast Feeding

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Study Officials

• Elif TAĞTEKİN, student

  Kahramanmaras Sutcu Imam University Department of Midwifery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine AKSÜT AKÇAY, Assistant Professor

CONTACT

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

Study Design

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

Model Details: The study sample was determined using a simple random sampling method among mothers in the early postpartum period (first 24-48 hours) at the Obstetrics and Gynecology Ward and Delivery Room Clinic of Kahramanmaraş Sütçü İmam University Medical Faculty Hospital, who agreed to participate in the study. The research was conducted using a pre-test and post-test quasi-experimental design with experimental and control groups. Pre-test data were collected by administering the Introductory Information Form, Breastfeeding Self-Efficacy Scale, and the Milk Ejection Reflex evaluation tool to participants who met the inclusion criteria and provided informed consent. Following the pre-test applications, participants were assigned to the experimental and control groups via a computer-generated random number table, and the sealed envelope method was used to ensure allocation concealment. As a result of randomization, a single session of oxytocin massage, lasting 20-30 minutes in total, was applied t

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 12, 2026
• Primary Completion: May 12, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)