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Completed

NCT Number: NCT07346339

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

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.

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Key information

Conditions

Newborn Diseases Behavior Breast Feeding Breast Milk Collection Breast Milk Expression Feeding Behavior MİNDFULNESS Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balcalı Hastanesi

Adana, Sarıçam, 01331, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensory Mindfulness Intervention

Behavioral

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.

Primary outcomes

  1. Breast Milk Volume (mL)

    Time frame: 2 WEEK

    The 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 outcomes

  1. Pumping Duration (minutes)

    Time frame: 2 WEEK

    The duration of each breast milk pumping session recorded in minutes using the Intervention Observation Form

  2. WHO-5 Well-Being Index Score

    Time frame: 2 WEEK

    Maternal psychological well-being assessed using the WHO-5 Well-Being Index. Higher scores indicate better well-being.

  3. Parental Stressor Scale: Neonatal Intensive Care Unit

    Time frame: 2 WEEK

    Maternal stress associated with the neonatal intensive care unit environment assessed using the PSS. Higher scores indicate greater stress levels.

  4. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

    Time frame: 2WEEK

    Maternal cognitive and affective mindfulness assessed using the CAMS-R. Higher scores indicate greater mindfulness.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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