An interventional study of Standard of Care and Mindfulness-based Intervention in Lactation, Mindfulness and NICU, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Other
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.
88 studies on the registry are indexed under Breast Milk Expression; 20 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 49 interventional studies indexed under Breast Milk Expression.
Browse Breast Milk Expression studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Compared within Breast Milk Expression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Feeding. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mothers in the standard of care arm will undergo a standard lactation admission visit
Behavioral: Standard of Care
Mothers in the mindfulness-based arm will receive mindfulness-based lactation education along with a standard lactation admission visit
Behavioral: Mindfulness-based Intervention
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.
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.
Change in breastmilk volume
Volume will be reported in milliliters (mL)
Time frame: Baseline, 10 days, 20 days
Change in salivary oxytocin
Time frame: Baseline, 10 days, 20 days
Change in salivary cortisol
Time frame: Baseline, 10 days, 20 days
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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