Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU

NCT07351799 — Not applicable, Recruiting, 40 participants, Mayo Clinic

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The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study

Registry	NCT07351799
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	40 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Lactation, Mindfulness, NICU, Breastmilk, Neonatal, Meditation, Pumping, Breast, Cortisol, Oxytocin, Anxiety, Depression
Interventions	Standard of Care, Mindfulness-based Intervention (Behavioral)
Dates	start 2025-09-22, primary completion 2026-11-02 (estimated), completion 2026-11-02 (estimated), first posted 2026-01-20, last updated 2026-01-20
Locations	1 site in United States

-Summary

The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard of Care	Active comparator	Behavioral: Standard of Care	Mothers in the standard of care arm will undergo a standard lactation admission visit
Mindfulness-Based	Experimental	Behavioral: Mindfulness-based Intervention	Mothers in the mindfulness-based arm will receive mindfulness-based lactation education along with a standard lactation admission visit

Standard of Care (Behavioral): No additional session with the lactation consultant will be provided beyond the standard of care lactation admission visit with a lactation consultant within 72 hours of their infant's admission to the NICU. On days 0, 10 and 20, participants will be asked to record pumping session times and breastmilk volumes expressed for 24 hours, collect salivary oxytocin sample and salivary cortisol sample at minute 4 of one pumping session, and fill out the GAD7, PSS, and PHQ-8 surveys.
Mindfulness-based Intervention (Behavioral): In addition to the standard of care lactation admission visit, participants will receive an additional session with the lactation consultant for mindfulness-based lactation education. Participants will also be provided with a pumping meditation audio recording that they will be asked to listen to at least once daily for the next 20 days. On days 0, 10 and 20, participants will be asked to record pumping session times and breastmilk volumes expressed for 24 hours, collect salivary oxytocin sample and salivary cortisol sample at minute 4 of one pumping session, and fill out the GAD7, PSS, and PHQ-8 surveys. In addition, the intervention group participants will also be asked to record the number of times they listened to the recording daily, minutes listened to recording daily, and time of day listened to recording.

+Outcome measures

Primary outcomes

Change in breastmilk volume [Baseline, 10 days, 20 days]: Volume will be reported in milliliters (mL)

Secondary outcomes

Change in salivary oxytocin [Baseline, 10 days, 20 days]
Change in salivary cortisol [Baseline, 10 days, 20 days]

+Eligibility

Sex: Female, ages: 20 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Maternal age > 20 years of age
* Read, write and understand English
* Infant NICU admit
* Infant birthplace of Rochester, MN (Mayo Clinic)
* Maternal adherence to pumping ≥ 8 times in 24 hours
* Mother enrolled within 72 hours of birth
* Gestational age of neonate at birth of < 34 0/7 weeks

Exclusion Criteria:

* Maternal extensive existing mindfulness practice
* Maternal breast/chest surgery
* Maternal polycystic ovarian syndrome (PCOS)
* Maternal current illicit substance abuse
* Diagnosis of maternal current severe mental health concerns
* Maternal multiple gestation (twins or higher order) pregnancy and delivery

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States	Recruiting

+Investigators

Ashley Thompson, Principal investigator, Mayo Clinic