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NCT Number: NCT07351799

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Alecia Robin, BSN, RN, IBCLC

SUB_INVESTIGATOR

Ashley Elizabeth Thompson, BSN, RN, IBCLC

PRINCIPAL_INVESTIGATOR

Ashley Thompson, BSN, RN, IBCLC

CONTACT

[email protected]

507-422-5523

Melissa Kurke, BSN, RN, IBCLC

SUB_INVESTIGATOR

Senna Hesbyn, BSN, RN, IBCLC

SUB_INVESTIGATOR

Tawney DeBoth, BSN, RN, IBCLC

CONTACT

[email protected]

507-422-5523

Tawney DeBoth, BSN, RN, IBCLC

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in breastmilk volume

    Time frame: Baseline, 10 days, 20 days

    Volume will be reported in milliliters (mL)

Secondary outcomes

  1. Change in salivary oxytocin

    Time frame: Baseline, 10 days, 20 days

  2. Change in salivary cortisol

    Time frame: Baseline, 10 days, 20 days

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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