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

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What is being tested

Standard of Care

+ Mindfulness-based Intervention
Behavioral
Who is being recruted

Anxiety Disorders
+5

+ Behavior
+ Mental Disorders
Over 20 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 22, 2025Actual date on which the first participant was enrolled.

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.

Official TitleThe Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study 
NCT07351799
Principal SponsorMayo Clinic
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 20 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Anxiety Disorders
Behavior
Mental Disorders
Behavioral Symptoms
Breast Feeding
Depression
Feeding Behavior
Breast Milk Expression
Criteria
7 inclusion criteria required to participate
Maternal age > 20 years of age
Read, write and understand English
Infant NICU admit
Infant birthplace of Rochester, MN (Mayo Clinic)

Show More Criteria

6 exclusion criteria prevent from participating
Maternal extensive existing mindfulness practice
Maternal breast/chest surgery
Maternal polycystic ovarian syndrome (PCOS)
Maternal current illicit substance abuse

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Mothers in the standard of care arm will undergo a standard lactation admission visit

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.
Group II
Experimental
Mothers in the mindfulness-based arm will receive mindfulness-based lactation education along with a standard lactation admission visit

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.
Study Objectives
Primary Objectives

Volume will be reported in milliliters (mL)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Mayo Clinic in RochesterRochester, United StatesSee the location
Recruiting
One Study Center