NCT07351799

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lactation
• Mindfulness
• NICU
• Breastmilk
• Neonatal
• Meditation
• Pumping, Breast
• Cortisol
• Oxytocin
• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Standard of Care	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.
BEHAVIORAL	Mindfulness-based Intervention	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.

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-11-02
• Completion: 2026-11-02
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States