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New program helps NICU moms feel less stressed and more connected

NCT ID NCT06958458

Symptom relief Sponsor: University of Yalova 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 4 times

Summary

This study tested a program called Mother Integrated Care for mothers of premature babies in the neonatal intensive care unit (NICU). The program trains mothers to actively participate in their baby's care, moving from being visitors to primary caregivers. Researchers measured stress and mother-baby bonding in 60 mothers, comparing those who received the training to those who did not.

What this could mean

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

Active substance
Mother Integrated Care (a behavioral training program)
What this could lead to
If successful, this approach could help reduce stress and improve bonding for mothers of premature babies in the NICU.
What could go wrong
This is a small, completed study with only 60 participants, so results may not apply to all mothers or hospitals. The program requires staff training and resources.

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

67 people

The number who actually took part.

Started

Aug 2025

Finished

Sep 2026

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

Accepted

You do not need to have the condition being studied to take part.

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: * The newborn must be premature (gestational age \>28 and \<34 weeks), * The infant must be admitted to the NICU and hospitalized for at least 3 days, * The mother must be open to communication and cooperation, * The mother must voluntarily agree to participate in the study, * The mother must be literate, * The mother must be able to speak and understand Turkish, * The mother must be primiparous and experiencing motherhood for the first time, * The mother must be over 18 years of age, * Mothers in the intervention group must be present in the hospital for an average of 6-8 hours per day. Exclusion Criteria: * The newborn has a congenital anomaly (e.g., craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis), * The newborn has a diagnosed gastrointestinal, neurological, or genetic disorder (e.g., necrotizing enterocolitis, hydrocephalus, Down syndrome, omphalocele, gastroschisis, short bowel syndrome, or other diseases), * The newborn has a congenital heart defect requiring surgical intervention, * The mother has a diagnosed psychiatric illness, * The mother and/or father do not wish to participate in the study. Withdrawal Criteria: * The mother does not attend the training sessions during the study period, * The mother fails to maintain cooperation throughout the study, * The newborn is transferred to another healthcare center for any reason, * The mother wishes to withdraw from the study, * The newborn is diagnosed with a chronic illness during the study process.

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Conditions

The condition(s) this trial relates to.

Empowerment Premature Birth

As listed by the trial registrant

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

Empowerment Mothers Premature

Contacts and locations

Locations

  • Yalova University

    Yalova, 77200, Turkey (Türkiye)

More trials for these conditions

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