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

January 12, 2026 updated by: Ashley E. Thompson, Mayo Clinic

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashley Elizabeth Thompson, BSN, RN, IBCLC
        • Sub-Investigator:
          • Tawney DeBoth, BSN, RN, IBCLC
        • Sub-Investigator:
          • Senna Hesbyn, BSN, RN, IBCLC
        • Sub-Investigator:
          • Melissa Kurke, BSN, RN, IBCLC
        • Sub-Investigator:
          • Alecia Robin, BSN, RN, IBCLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in breastmilk volume
Time Frame: Baseline, 10 days, 20 days
Volume will be reported in milliliters (mL)
Baseline, 10 days, 20 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in salivary oxytocin
Time Frame: Baseline, 10 days, 20 days
Baseline, 10 days, 20 days
Change in salivary cortisol
Time Frame: Baseline, 10 days, 20 days
Baseline, 10 days, 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ashley Thompson, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2025

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 2, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-013742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Standard of Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe