Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress (NCT07346339) | Clinical Trial Compass
CompletedNot Applicable
Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress
Turkey (Türkiye)60 participantsStarted 2025-09-30
Plain-language summary
Abstract Background: Breast milk is the optimal source of nutrition for infant growth and development and provides important physical and psychological benefits for mothers. Because many infants in the Neonatal Intensive Care Units (NICU) cannot be breastfed directly, mothers are required to express milk regularly; however, stress, anxiety, and depression may negatively affect milk production and the milk ejection reflex. This study aims to evaluate the effect of the sensory mindfulness intervention on breast milk volume, pumping duration, maternal well-being, stress levels, and cognitive and emotional mindfulness.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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
* Having an infant hospitalized in the neonatal intensive care unit
* Expressing breast milk for the infant
* Having a term newborn
* Not having twins
* Having no health condition that would prevent participation in the study
* Being able to speak Turkish
* Volunteering to participate in the research. Exclusion criteria
* Missing two or more intervention sessions
* Leaving more than 5% of the questionnaire's incomplete
* The newborn having a high risk of morbidity or mortality
* The presence of a congenital malformation in the newborn
* Undergoing a surgical procedure during the study period
* Having a history of a physical or mental condition that could hinder participation or receiving psychological treatment before or during the intervention.
Termination criteria
* The participant expressing a wish to withdraw from the study at any stage
* Inability to complete the data collection protocol due to the end of the newborn's NICU hospitalization (discharge, transfer etc.)
* Failure to maintain adherence to the research protocol (e.g., inability to complete planned milk expression records or scale administrations)
* The development of a clinical condition during the study that prevented participation in the intervention or assessments (e.g., an acute health problem, treatment requiring sedation, or the need for intensive medical intervention)
* A determination by the research team that continuation was not appropriate in terms of safety or data integrity.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.