Health TrialsbyHealthPanel

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

ConditionsLactationMindfulnessNICUBreastmilkNeonatalMeditationPumping, BreastCortisolOxytocinAnxietyDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Maternal age > 20 years of age

Read, write and understand English

Infant NICU admit

Infant birthplace of Rochester, MN (Mayo Clinic)

Disqualifiers

Maternal extensive existing mindfulness practice

Maternal breast/chest surgery

Maternal polycystic ovarian syndrome (PCOS)

Maternal current illicit substance abuse

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care

    Behavioral

    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

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: Mindfulness-BasedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in breastmilk volume

Volume will be reported in milliliters (mL)

Time frame
Baseline, 10 days, 20 days

Secondary outcomes

1

Change in salivary oxytocin

Time frame
Baseline, 10 days, 20 days
2

Change in salivary cortisol

Time frame
Baseline, 10 days, 20 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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