- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346339
Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress
June 25, 2026 updated by: Emel Yürük, Cukurova University
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sarıçam
-
Adana, Sarıçam, Turkey (Türkiye), 01331
- Balcalı Hastanesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 WEEK
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pumping Duration (minutes)
Time Frame: 2 WEEK
|
The duration of each breast milk pumping session recorded in minutes using the Intervention Observation Form
|
2 WEEK
|
|
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.
|
2 WEEK
|
|
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.
|
2 WEEK
|
|
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.
|
2WEEK
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2025
Primary Completion (Actual)
November 30, 2025
Study Completion (Actual)
December 20, 2025
Study Registration Dates
First Submitted
June 13, 2025
First Submitted That Met QC Criteria
January 8, 2026
First Posted (Actual)
January 16, 2026
Study Record Updates
Last Update Posted (Actual)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 25, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Çukurova U Ethics Commit 19/42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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