LactationNCT07351799
Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU
A study testing Mindfulness-based Intervention in people with Lactation and Mindfulness, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation, Mindfulness, NICU
- What is being tested?
- Mindfulness-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to 2 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Ashley Thompson, BSN, RN, IBCLC, 507-422-5523, NICULactationStu@mayo.edu
Tawney DeBoth, BSN, RN, IBCLC, 507-422-5523, NICULactationStu@mayo.edu
About this study
Official title: 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.
- Conditions
- Lactation, Mindfulness, NICU, Breastmilk, Neonatal, Meditation
- Being tested
- Standard of Care, Mindfulness-based Intervention
- Keywords
- lactation, mindfulness, NICU, breastmilk, Neonatal, meditation, pumping, breast, cortisol, oxytocin, anxiety, Depression
- Medical subject headings
- Breast Feeding, Breast Milk Expression, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
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 InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Mothers in the standard of care arm will undergo a standard lactation admission visit Receives: 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 Receives: Behavioral: Mindfulness-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breastmilk volume
Volume will be reported in milliliters (mL)
Measured: Baseline, 10 days, 20 days
Secondary outcomes (2)
Change in salivary oxytocin
Measured: Baseline, 10 days, 20 days
Change in salivary cortisol
Measured: Baseline, 10 days, 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start22 Sep 2025
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley E. Thompson, Mayo Clinic
- Investigators
- Ashley Thompson, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351799
- Sponsor's protocol ID
- 24-013742
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study
- ClinicalTrials.gov ID
- NCT07351799
- Acronym / sponsor ID
- 24-013742
- Conditions
- Lactation, Mindfulness, NICU, Breastmilk, Neonatal, Meditation
- Keywords
- lactation, mindfulness, NICU, breastmilk, Neonatal, meditation, pumping, breast, cortisol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Standard of CareMothers in the standard of care arm will undergo a standard lactation admission visit |
| Mindfulness-Based | Experimental | Behavioral: Mindfulness-based InterventionMothers in the mindfulness-based arm will receive mindfulness-based lactation education along with a standard lactation admission visit |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareNo 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. | Behavioural | Standard of Care |
| Mindfulness-based InterventionIn 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. | Behavioural | Mindfulness-Based |
Primary outcome
Change in breastmilk volume
Time frame: Baseline, 10 days, 20 days
Volume will be reported in milliliters (mL)
2 secondary outcomes
Change in salivary oxytocin
Time frame: Baseline, 10 days, 20 days
Change in salivary cortisol
Time frame: Baseline, 10 days, 20 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Thompson principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention in people with Lactation and Mindfulness, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breastmilk volume (time frame: Baseline, 10 days, 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.