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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07351799
Enrollment
40
Registered
2026-01-20
Start date
2025-09-22
Completion date
2026-11-02
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

lactation, mindfulness, NICU, breastmilk, Neonatal, meditation, pumping, breast, cortisol, oxytocin, anxiety, Depression

Brief 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.

Interventions

BEHAVIORALStandard 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.

BEHAVIORALMindfulness-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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in breastmilk volumeBaseline, 10 days, 20 daysVolume will be reported in milliliters (mL)

Secondary

MeasureTime frame
Change in salivary oxytocinBaseline, 10 days, 20 days
Change in salivary cortisolBaseline, 10 days, 20 days

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAshley Thompson

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026