Recruiting

Mindfulness & Meditation

Sponsor:

Mayo Clinic

Code:

NCT07351799

Conditions

Lactation

Mindfulness

NICU

Breastmilk

Neonatal

Eligibility Criteria

Sex: Female

Age: 20+

Healthy Volunteers: Accepted

Interventions

Standard of Care

Mindfulness-based Intervention

Study Details

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.

Conditions

Lactation

Mindfulness

NICU

Breastmilk

Neonatal

Study ID

NCT07351799

Start date

Sep 22, 2025

Status verified date

Jan, 2026

Completion date

Nov 2, 2026

Anticipated

Primary completion date

Nov 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

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

experimental: Mindfulness-Based

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

Interventions

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.

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.

Primary outcome measure

  • Change in breastmilk volume [ Time Frame: Baseline, 10 days, 20 days ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ashley Thompson, BSN, RN, IBCLC

507-422-5523NICULactationStu@mayo.edu

Tawney DeBoth, BSN, RN, IBCLC

507-422-5523NICULactationStu@mayo.edu

Principal Investigator:

Ashley Elizabeth Thompson, BSN, RN, IBCLC

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • lactation
  • mindfulness
  • NICU
  • breastmilk
  • Neonatal
  • meditation
  • pumping, breast
  • cortisol
  • oxytocin
  • anxiety
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-20.