Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Over 20 Years
Eligible Sex: Female
Accepts 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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Standard of Care	Mothers in the standard of care arm will undergo a standard lactation admission visit	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.
Experimental Mindfulness-Based	Mothers in the mindfulness-based arm will receive mindfulness-based lactation education along with a standard lactation admission visit	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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Mayo Clinic

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.