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Completed
NCT07346339
Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress
Conditions: Newborn Diseases, Breast Milk Collection, Well-being, MİNDFULNESS
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Cukurova University
Location: Balcalı Hastanesi Adana Sarıçam
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07346339). StuddyBuddy aggregates publicly available trial information.