Recruiting NCT07351799
Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care, Mindfulness-based Intervention.
- Who it may be relevant to
- Registry conditions: Lactation, Mindfulness, NICU, Breastmilk. Basic parameters: from 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study
Overview
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 sampl
Primary outcome measures
- Change in breastmilk volume [Time frame: Baseline, 10 days, 20 days]
Secondary outcome measures (2)
- Change in salivary oxytocin [Time frame: Baseline, 10 days, 20 days]
- Change in salivary cortisol [Time frame: Baseline, 10 days, 20 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07351799 · 24-013742