NCT07351799

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Sep 2025Nov 2026

Study Start

First participant enrolled

September 22, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

LactationMindfulnessNICUBreastmilkNeonatalMeditationPumping, BreastCortisolOxytocinAnxietyDepression

Keywords

lactationmindfulnessNICUbreastmilkNeonatalmeditationpumping, breastcortisoloxytocinanxietyDepression

Outcome Measures

Primary Outcomes (1)

  • Change in breastmilk volume

    Volume will be reported in milliliters (mL)

    Baseline, 10 days, 20 days

Secondary Outcomes (2)

  • Change in salivary oxytocin

    Baseline, 10 days, 20 days

  • Change in salivary cortisol

    Baseline, 10 days, 20 days

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Mothers in the standard of care arm will undergo a standard lactation admission visit

Behavioral: Standard of Care

Mindfulness-Based

EXPERIMENTAL

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

Behavioral: Mindfulness-based Intervention

Interventions

Standard of CareBEHAVIORAL

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.

Standard of Care
Mindfulness-based InterventionBEHAVIORAL

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.

Mindfulness-Based

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast FeedingBreast Milk ExpressionAnxiety DisordersDepression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorMental DisordersBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ashley Thompson

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 20, 2026

Study Start

September 22, 2025

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 2, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)