Meditation for NICU Moms

This project explores whether meditation increases breastmilk supply in mothers who are pumping milk for infants in the NICU. Mothers will be randomly assigned to daily meditation while pumping using an app designed for meditation for new mothers, and their breastmilk volume will be measured after one week of meditation versus a control group with measurements at the same time points. Investigators will also determine whether mediation improves breastfeeding confidence and reduces stress, anxiety and depression symptoms in these mothers. Finally investigators will examine the effect on salivary cortisol levels.

Study Overview

• Status: Completed
• Conditions: Stress; Premature Birth; Depression, Postpartum; Anxiety; Breast Feeding; Self Efficacy; Behavior, Maternal; Insufficient Lactation
• Intervention / Treatment: Behavioral: Meditation

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Richmond Heights, Missouri, United States, 63117
      • St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 1) Mothers of all ages, including emancipated minors will be included 2) Gestational age at birth of 24 completed weeks to 32 weeks 6 days 3) Mothers of infants admitted to St. Mary's NICU or with transfer or anticipated transfer to Cardinal Glennon NICU 4) Mothers who intend to provide breastmilk to infants for at least 1 month. 5) Recruitment within 24 hours of time of delivery in order to allow for beginning of 24 hour milk collection at 24 hours post delivery

Exclusion Criteria:

• 1) Mothers of infants expected to be nippling at the breast in less than 10 days 2) Infants for whom discharge is anticipated in less than 10 days 3) Participation in another interventional study at Screening or who plan to participate in another interventional study during the study period 4) Hearing loss that would preclude participation in meditation recordings 5) Inability to come for a midday (between 11am -3pm) visit on day of life #10. 6) Inability or unwillingness to perform the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditation Group; Twenty minutes of daily meditation for 7 days. Routine lactation support.	Behavioral: Meditation; Daily meditation; Other Names: Expectful App meditation
No Intervention: Control Group; Routine lactation support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour breast milk volume	24 hours volume of pumped milk after 7 days of daily meditation collected versus change in pumped milk volume among mothers in a control group	Post-Intervention/Infant Day of Life #9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Score:NICU	Comparison in the change in scores of Perceived Stress Score: NICU between Meditation Group and Control Group. This is a 26-question written questionnaire that evaluates parental stress in relation to the experiences of having an infant in the NICU. Subscales are the following: Sights and Sounds (5 questions) Baby looks and behaves and Treatments (14 questions) Relationship/Parental Role (7 questions) Question responses are on a scale of NA, 1, 2, 3, 4, 5 Total scores range from NA to 130.A higher score on the scale indicates higher stress.	Post-intervention/Infant Day of Life # 10
State-Trait Anxiety Inventory (STAI)	Comparison in the change in scores of State-Trait Anxiety Inventory between Meditation Group and Control Group. This is a 40-question written questionnaire that evaluates anxiety symptoms. Comparison of Baseline/Infant Day of Life #1 to Post-intervention/Infant Day of Life # 10. Question responses are on a scale of 1-4 Total score ranges from 40-160. Scores are weighted using a scoring tool. A higher score is higher anxiety.	Post-intervention/Infant Day of Life # 10
Edinburgh Postnatal Depression Scale (EPDS)	Comparison in the change in scores of Edinburgh Postnatal Depression Scale between the Meditation Group and Control Group This is a 10-question written questionnaire that evaluates depression symptoms. Maximum Score: 30 Possible Depression: 10 or greater Score 13 or greater = likely to be suffering from a depressive illness of varying severity Always look at Item 10 (suicidal thoughts)	Post-intervention/Infant Day of Life # 10
Breastfeeding Self-Efficacy Scale-short Form with additional questions for critically ill infants	Comparison of scores Breastfeeding Self-Efficacy Scale-short Form with additional questions for critically ill infants between the Meditation Group and Control Group This is a 18-question questionnaire that evaluates breastfeeding self-efficacy in breastfeeding mothers of infants in the NICU. This scale will be used to assess breastfeeding self-efficacy. Question responses are on a scale of 1-5. Total score ranges from 18- 9. A higher score indicates higher confidence.	Post-intervention/Infant Day of Life # 10
Salivary Cortisol - Hormonal regulation of breastfeeding and stress response	Diurnal salivary cortisol slope and cortisol awakening response with meditation versus without meditation.	Infant Day of Life #9
Serum Cortisol hormone -Hormonal regulation of breastfeeding and stress response	Cortisol hormone during milk expression with meditation versus without meditation.	Infant Day of Life #10
Serum Adrenocorticotrophic hormone -Hormonal regulation of breastfeeding and stress response	Adrenocorticotrophic hormone during milk expression with meditation versus without meditation.	Infant Day of Life #10
Serum Catecholamines -Hormonal regulation of breastfeeding and stress response	Catecholamines during milk expression with meditation versus without meditation.	Infant Day of Life #10
Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response	Dihydroepiandosterone during milk expression with meditation versus without meditation.	Infant Day of Life #10
Number of skin-to-skin episodes -Lactation promoting behaviors	Number of skin-to-skin episodes between Infant Day of Life #1 and Infant Day of Life #9 recorded in daily diary	Day of Life #1 through Infant Day of Life #9
Use of hand expression - Lactation promoting behaviors	Use of hand expression with breastmilk pumping	Infant Day of Life #9
Pumping episodes -Lactation promoting behaviors	number of reported pumping episodes reported in 24-hour milk collection log	Post-Intervention/Infant Day of Life #9
Supplementation of infant feeding with formula or donor human breastmilk	Supplementation of infant feeding with formula or donor human breastmilk	4 weeks post-partum
Sustained breastfeeding at 4 weeks postpartum	Sustained breastfeeding at 4 weeks postpartum, supplementation feeding with formula or donor milk at 2 and 4 weeks postpartum Mother is asked if she is still providing breast milk (No/Yes) and if Baby is fed exclusively with mother's breastmilk (No/Yes) at 2 and 4 weeks postpartum	4 weeks postpartum
Duration of meditation	Duration of meditation at 4 weeks postpartum	4 weeks postpartum

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Obstetric Labor, Premature; Depressive Disorder; Depression, Postpartum; Premature Birth
• Other Study ID Numbers: 29082

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No