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

NCT07346339 | Completed

• 1 other identifier: Çukurova U Ethics Commit 19/42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Breast milk; well-being; MİNDFULNESS

Outcome Measures

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.

  2 WEEK

Secondary Outcomes (4)

• Pumping Duration (minutes)

  2 WEEK

• WHO-5 Well-Being Index Score

  2 WEEK

• Parental Stressor Scale: Neonatal Intensive Care Unit

  2 WEEK

• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

  2WEEK

Study Arms (2)

Sensory Mindfulness Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

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.

Sensory Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Balcalı Hastanesi

Adana, Sarıçam, 01331, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral instructor

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: January 16, 2026
• Study Start: September 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 20, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)