Actively Recruiting
The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study
Led by Mayo Clinic · Updated on 2026-01-20
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how mindfulness and meditation techniques might influence changes in breastmilk among mothers pumping for their infants in the Neonatal Intensive Care Unit (NICU). This study focuses on mothers whose infants were born prematurely with a gestational age under 34 weeks and admitted to the NICU. The purpose is to understand associations between mindfulness-based lactation education and maternal breastmilk volume and related hormonal changes. Participants are randomly assigned to one of two groups. The standard of care group receives a typical lactation admission visit from a lactation consultant within 72 hours of their infant's NICU admission. The mindfulness-based group receives this standard visit plus an additional session focused on mindfulness-based lactation education and a daily meditation audio recording to listen to during pumping for 20 days. Both groups record pumping times and breastmilk volumes and provide saliva samples for oxytocin and cortisol analysis at baseline, 10 days, and 20 days. Throughout the 20-day study period, mothers track their pumping sessions, breastmilk volume, and complete surveys assessing anxiety and stress. The mindfulness group also logs their usage of the meditation audio. Researchers monitor changes in breastmilk volume as the primary outcome and changes in salivary oxytocin and cortisol as secondary outcomes. This study evaluates how mindfulness practices might impact lactation and hormonal responses in mothers with NICU infants.
CONDITIONS
Brief Title
Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age greater than 20 years
- Ability to read, write, and understand English
- Infant admitted to the Neonatal Intensive Care Unit (NICU)
- Infant born in Rochester, MN (Mayo Clinic)
- Maternal pumping adherence of at least 8 times in 24 hours
- Enrollment within 72 hours of birth
- Neonate gestational age at birth less than 34 weeks
You will not qualify if you...
- Extensive existing maternal mindfulness practice
- Maternal history of breast or chest surgery
- Maternal diagnosis of polycystic ovarian syndrome (PCOS)
- Current maternal illicit substance abuse
- Diagnosis of current severe maternal mental health concerns
- Maternal multiple gestation pregnancy and delivery (twins or higher)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Enrollment occurs within 72 hours of birth
Duration - 20 days
Participants receive lactation education and support. Those in the mindfulness-based group receive an additional mindfulness-based lactation education session and a meditation audio recording to use daily for 20 days.
1 lactation admission visit and assessments on days 0, 10, and 20
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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