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Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress

The Effect of Sensory Mindfulness Technique on Breast Milk, Maternal Well-Being, and Stress Levels in Mothers Whose Infants Are Undergoing Treatment in the Neonatal Intensive Care Unit and Are Breastfeeding With Expressed Breast Milk

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07346339
Enrollment
60
Registered
2026-01-16
Start date
2025-09-30
Completion date
2025-12-20
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk Collection, MİNDFULNESS, Newborn Diseases, Well-being

Keywords

Breast milk, well-being, MİNDFULNESS

Brief 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.

Interventions

BEHAVIORALSensory Mindfulness Intervention

Sensory mindfulness intervention consisting of infant scent exposure (using a beanie worn by the infant), infant photograph visualization, positive thinking, and sensory awareness exercises performed for approximately 8-10 minutes before each breast milk pumping session. The intervention was administered over a 14-day period in addition to standard breast milk pumping education.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Participants who met the eligibility criteria were randomly assigned in a 1:1 ratio to either the sensory mindfulness intervention group or the standard care control group. Mothers in the intervention group received a structured sensory mindfulness practice consisting of infant scent exposure (using a beanie worn by the infant), infant photograph visualization, positive thinking, and sensory awareness exercises performed for approximately 8-10 minutes before each milk pumping session over a 14-day period. Mothers in the control group received routine breast milk pumping education and standard care only. Outcomes, including breast milk volume, pumping duration, maternal well-being, stress levels, and cognitive-affective mindfulness, were assessed at baseline and during follow-up measurements throughout the intervention period.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Breast Milk Volume (mL)2 WEEKThe amount of expressed breast milk (mL) measured during the study period. Milk volume was recorded separately for morning and evening pumping sessions using the Intervention Observation Form.

Secondary

MeasureTime frameDescription
Pumping Duration (minutes)2 WEEKThe duration of each breast milk pumping session recorded in minutes using the Intervention Observation Form
WHO-5 Well-Being Index Score2 WEEKMaternal psychological well-being assessed using the WHO-5 Well-Being Index. Higher scores indicate better well-being.
Parental Stressor Scale: Neonatal Intensive Care Unit2 WEEKMaternal stress associated with the neonatal intensive care unit environment assessed using the PSS. Higher scores indicate greater stress levels.
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)2WEEKMaternal cognitive and affective mindfulness assessed using the CAMS-R. Higher scores indicate greater mindfulness.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026