Recruiting
Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU
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.
ClinicalTrials.gov IDNCT07351799
PhaseNA
Enrollment40
SponsorMayo Clinic
Age20 Years
SexFEMALE
Conditions studied
Lactation, Mindfulness, NICU, Breastmilk, Neonatal, Meditation, Pumping, Breast, Cortisol, Oxytocin, Anxiety, Depression
About this study
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
- 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.
Primary outcomes
- Change in breastmilk volume (Baseline, 10 days, 20 days)
Eligibility information
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
Study locations
- Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.