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Lactation DisordersNCT07609693

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

A study testing Oxytocin Massage in people with Lactation Disorders, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Lactation Disorders
What is being tested?
Oxytocin Massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 May 2026to 12 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.)
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emine AKSÜT AKÇAY, Assistant Professor contact

(344) 300- 2654

emineaksutakcay@ksu.edu.tr/

Turkey (Türkiye)1 site, 1 recruiting
  • Kahramanmaras Sutcu Imam University Hospital, Department of Obstetrics and Gynecology, Delivery Room

    Kahramanmaraş, Merkez, 46100

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Breastfeeding is a fundamental public health intervention in protecting maternal and neonatal health, and the early postpartum period is particularly critical for the initiation and maintenance of lactation (WHO, 2023). Effective breastfeeding initiated in the first hours and days of life reduces neonatal mortality and positively affects long-term mother-infant health (Victora et al., 2023). However, physiological, psychological, and environmental factors experienced in the early postpartum period can negatively impact breastfeeding success. During this period, the mother's hormonal balance, birth experience, fatigue level, and emotional adaptation are among the main factors determining the quality of the breastfeeding process.

One of the most frequently reported problems by mothers in the early postpartum period is insufficient milk supply or perceived insufficient milk (Brown et al., 2022). Perceived insufficient milk is often related to maternal stress, anxiety, pain, and negative perceptions regarding the birth experience rather than objective milk production (Fallon et al., 2021). Increased stress levels can suppress oxytocin release through the hypothalamic-pituitary axis, thereby reducing the effectiveness of the milk ejection reflex (Uvnäs-Moberg et al., 2020). Inadequate realization of the milk ejection reflex can lead to delayed milk flow despite a feeling of fullness in the breast, making the mother's breastfeeding experience difficult. Recurrent negative experiences can lower the mother's perception of self-efficacy regarding breastfeeding (Dennis \& Jackson, 2021).

The lactation process is regulated by the coordinated action of prolactin and oxytocin hormones. While prolactin is responsible for milk synthesis, oxytocin ensures the realization of the milk ejection reflex (Uvnäs-Moberg et al., 2020). Oxytocin is not only a peripheral hormone but also a neuropeptide that has stress-reducing and attachment-supporting effects at the central nervous system level. Increased oxytocin levels are reported to be associated with maternal relaxation, a sense of trust, and mother-infant bonding (Feldman, 2021). Therefore, non-pharmacological interventions that support oxytocin release can positively affect both physiological milk flow and the mother's psychological adaptation process.

Oxytocin massage is an intervention applied to the thoracic paravertebral region that aims to increase oxytocin release through afferent nerve stimulation. Although this method, frequently used in clinical practice, has been reported to have positive effects on milk production and milk volume (Kusumastuti et al., 2021; Pramono et al., 2022), it is observed that randomized controlled trials evaluating the effectiveness of the milk ejection reflex and its relationship with psychosocial variables together are limited. The fact that most existing studies have a quasi-experimental design highlights the need to strengthen the level of evidence.

Breastfeeding self-efficacy is based on the concept of self-efficacy, which is grounded in Bandura's social cognitive theory and expresses an individual's belief that they can successfully perform a specific behavior (Dennis, 2020). Self-efficacy is nourished by four main sources: performance accomplishments, verbal persuasion, vicarious experience (observational learning), and physiological-emotional states. Physiological difficulties and inadequacy in the milk ejection reflex experienced in the early postpartum period can negatively affect the mother's physiological-emotional state, leading to a decrease in self-efficacy perception (Brady et al., 2021). Low breastfeeding self-efficacy has been found to be associated with early cessation of breastfeeding (Fallon et al., 2021).

When the literature is reviewed, although there are studies examining the effect of oxytocin massage on milk volume, it is noteworthy that randomized controlled trials addressing the milk ejection reflex and breastfeeding self-efficacy together are limited. The lack of studies with a high level of evidence aimed at evaluating these variables together, especially in mothers experiencing insufficient milk supply, creates an important gap in terms of developing evidence-based midwifery practices. In this context, this study aimed to investigate the effect of oxytocin massage applied to mothers with insufficient milk supply in the early postpartum period on breastfeeding self-efficacy and the milk ejection reflex using a randomized controlled design. The study is expected to contribute to the literature regarding the effectiveness of non-pharmacological interventions for breastfeeding support in the early postpartum period.

Hypotheses:

H0a: Oxytocin massage applied to mothers with insufficient milk supply in the early postpartum period does not affect breastfeeding self-efficacy.

H1a: Oxytocin massage applied to mothers with insufficient milk supply in the early postpartum period leads to a change in the level of breastfeeding self-efficacy over time.

H0b: Oxytocin massage applied to mothers with insufficient milk supply in the early postpartum period does not affect the milk ejection reflex.

H1b: Oxytocin massage applied to mothers with insufficient milk supply in the early postpartum period leads to a change in the level of the milk ejection reflex over time.

Being tested
Oxytocin Massage
Keywords
Lactation Disorders, Breast Feeding, Postpartum Period
Medical subject headings
Lactation Disorders, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxytocin MassageOther

    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.

Study groups in NCT07609693
Study groupRoleWhat they receive
Oxytocin Massage GroupExperimentalMothers 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.
Receives: Other: Oxytocin Massage
Routine Care GroupNo interventionMothers assigned to this group will not receive any additional experimental interventions. They will only receive the institution's routine standard postpartum hospital care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Perception of Insufficient Milk Supply Questionnaire

    Maternal perception of milk supply was evaluated using this 6-item questionnaire. The first question is a yes/no item ("Do you believe you produce enough milk to satisfy your baby?"). The remaining 5 items are scored from 0 to 10 (0 = completely insufficient, 10 = completely sufficient). The total score for these 5 items ranges from 0 to 50. Higher scores indicate a higher perception of sufficient milk supply.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start12 May 2026
  3. Primary completion12 May 2026
  4. Study completion12 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609693
Sponsor's protocol ID
2026/11 -08
Status last verified
Feb 2026
First submitted
20 May 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to protect the privacy and confidentiality of the postpartum mothers involved in the study. The informed consent obtained from the participants strictly limits the use of their data to this specific research only. Furthermore, the institutional ethics committee approval does not cover public data sharing or secondary analysis by third parties.

Questions about this trial

What is this clinical trial studying?

A study testing Oxytocin Massage in people with Lactation Disorders, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emine AKSÜT AKÇAY, Assistant Professor ((344) 300- 2654, emineaksutakcay@ksu.edu.tr/), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Self-Efficacy Scale-Short Form (time frame: Baseline (immediately before the intervention) and immediately after the single 20-30 minute session of oxytocin massage.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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