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CompletedNCT07346339Updated Jun 30, 2026

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

An interventional study of Sensory Mindfulness Intervention in Newborn Diseases, Breast Milk Collection and Well-being, sponsored by Cukurova University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Cukurova University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Breast milk
  • well-being
  • MİNDFULNESS
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Sensory Mindfulness Intervention

    Mothers who met the eligibility criteria were randomly assigned to the sensory mindfulness intervention group. After providing informed consent, participants completed the Descriptive Information Form, WHO-5 Well-Being Index, Parental Stressor Scale: NICU (PSS:NICU), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Mothers received standard training on breast milk pumping techniques and structured sensory mindfulness training. The intervention included exposure to the infant's scent using a beanie worn by the infant, visualization of the infant, viewing the infant's photograph, and positive thinking/sensory awareness exercises. Mothers performed the sensory mindfulness practice for approximately 8-10 minutes before each pumping session over a 14-day period. Breast milk volume (mL) and pumping duration (minutes) were recorded at baseline and follow-up assessments conducted on Days 1, 2, 3, 4, 5, 6, 7, and 14.

    Behavioral: Sensory Mindfulness Intervention

  • No intervention
    Control Group

    Mothers assigned to the control group received routine care and standard breast milk pumping education only. Participants completed the Descriptive Information Form, WHO-5 Well-Being Index, Parental Stressor Scale: NICU (PSS:NICU), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Breast milk volume (mL) and pumping duration (minutes) were recorded at baseline and follow-up assessments conducted on Days 1, 2, 3, 4, 5, 6, 7, and 14. No mindfulness, relaxation, or sensory awareness intervention was provided.

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.

05

What researchers measure

Primary outcomes

  1. Breast Milk Volume (mL)

    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.

    Time frame: 2 WEEK

Secondary outcomes

  1. Pumping Duration (minutes)

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

    Time frame: 2 WEEK

  2. WHO-5 Well-Being Index Score

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

    Time frame: 2 WEEK

  3. Parental Stressor Scale: Neonatal Intensive Care Unit

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

    Time frame: 2 WEEK

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

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

    Time frame: 2WEEK

06

Study locations

1 site
  • Balcalı Hastanesi
    Adana, Sarıçam 01331, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07346339
Lead sponsor
Cukurova University
Responsible party
Emel Yürük (Doctoral instructor, Cukurova University) — Principal investigator
First posted
Jan 16, 2026
Start date
Sep 30, 2025
Primary completion
Nov 30, 2025
Completion
Dec 20, 2025
Last update
Jun 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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