Newborn DiseasesNCT07346339
Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress
A study testing Sensory Mindfulness Intervention in people with Newborn Diseases and Breast Milk Collection, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Newborn Diseases, Breast Milk Collection, Well-being
- What is being tested?
- Sensory Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Sensory Mindfulness Intervention
- Keywords
- Breast milk, well-being, MİNDFULNESS
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Mindfulness InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 WEEK
Secondary outcomes (4)
Pumping Duration (minutes)
The duration of each breast milk pumping session recorded in minutes using the Intervention Observation Form
Measured: 2 WEEK
WHO-5 Well-Being Index Score
Maternal psychological well-being assessed using the WHO-5 Well-Being Index. Higher scores indicate better well-being.
Measured: 2 WEEK
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.
Measured: 2 WEEK
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Maternal cognitive and affective mindfulness assessed using the CAMS-R. Higher scores indicate greater mindfulness.
Measured: 2WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Sep 2025
- Primary completion30 Nov 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn DiseasesStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Yürük, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346339
- Sponsor's protocol ID
- Çukurova U Ethics Commit 19/42
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07346339
- Acronym / sponsor ID
- Çukurova U Ethics Commit 19/42
- Conditions
- Newborn Diseases, Breast Milk Collection, Well-being, MİNDFULNESS
- Keywords
- Breast milk, well-being, MİNDFULNESS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sensory Mindfulness Intervention | Experimental | Behavioral: Sensory Mindfulness InterventionMothers 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Mindfulness InterventionSensory 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. | Behavioural | Sensory Mindfulness Intervention |
Primary outcome
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.
4 secondary outcomes
Pumping Duration (minutes)
Time frame: 2 WEEK
WHO-5 Well-Being Index Score
Time frame: 2 WEEK
Parental Stressor Scale: Neonatal Intensive Care Unit
Time frame: 2 WEEK
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time frame: 2WEEK
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Mindfulness Intervention in people with Newborn Diseases and Breast Milk Collection, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Milk Volume (mL) (time frame: 2 WEEK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.