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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07351799
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 22, 2025
Status verified
Jan 2026
Primary completion
Nov 2, 2026
Completion
Nov 2, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Standard of Care
    Mothers in the standard of care arm will undergo a standard lactation admission visit
  • Experimental: Mindfulness-Based
    Mothers in the mindfulness-based arm will receive mindfulness-based lactation education along with a standard lactation admission visit

Primary Outcome Measure

Change in breastmilk volume [ Time Frame: Baseline, 10 days, 20 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Ashley Thompson, BSN, RN, IBCLC
[email protected]
507-422-5523
Tawney DeBoth, BSN, RN, IBCLC
[email protected]
507-422-5523
Ashley Elizabeth Thompson, BSN, RN, IBCLC (PRINCIPAL_INVESTIGATOR)
Tawney DeBoth, BSN, RN, IBCLC (SUB_INVESTIGATOR)
Senna Hesbyn, BSN, RN, IBCLC (SUB_INVESTIGATOR)
Melissa Kurke, BSN, RN, IBCLC (SUB_INVESTIGATOR)
Alecia Robin, BSN, RN, IBCLC (SUB_INVESTIGATOR)

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