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Could calming Moms-to-Be boost baby brain health?

NCT ID NCT06876051

Prevention Sponsor: National and Kapodistrian University of Athens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a prenatal stress management program, which teaches relaxation techniques like deep breathing and guided imagery, can help new mothers breastfeed longer and support their baby's early brain development. The study will include 162 first-time pregnant women and compare those who receive the program with those who don't. Researchers will measure breastfeeding success, infant behavior, and levels of certain brain-related proteins in the mother and baby's blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A prenatal stress management program combining relaxation techniques (diaphragmatic breathing, progressive muscle relaxation, guided imagery) and breastfeeding education.
What this could lead to
If effective, this program could offer a simple, drug-free way to improve breastfeeding rates and support healthy infant brain development.
What could go wrong
This is a relatively small trial, and results may not apply to all populations. The benefits are uncertain, and the program requires time and commitment from participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

162 people

The number who actually took part.

Started

Feb 2018

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Primiparous pregnant women * 14-20 weeks of Gestational Age * Intention to give birth at the specific maternity hospital * Greek women or foreigners who know the Greek language very well * Place of residence: Greece Exclusion Criteria: * Use of benzodiazepines, major neuroleptics, or psychostimulant medications. * Pregnant women diagnosed with incurable physical or mental diseases. * Pregnant women carrying fetuses or newborns with major congenital anomalies or criteria for perinatal asphyxia. * Pregnant women with stillbirths or newborns who do not survive. * All mothers and their newborns born before 34 weeks of gestation or requiring hospitalization in the Neonatal Intensive Care Unit (NICU) for more than 7 days.

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Conditions

The condition(s) this trial relates to.

Breast Feeding Infant Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breastfeeding Infant behavior Prenatal stress Relaxation Stress

Contacts and locations

Locations

  • Maternity Hospital "ELENA VENIZELOU"

    Athens, Attica, 11521, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.