Meditation for NICU Moms

Study Overview
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Brief Summary
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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.

Official Title
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Meditation for NICU Moms

Conditions
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Breast Feeding, Premature Birth, Stress, Depression, Postpartum, Anxiety, Self Efficacy, Behavior, Maternal, Insufficient Lactation

Intervention / Treatment
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* Behavioral: Meditation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation Group<br>Twenty minutes of daily meditation for 7 days. Routine lactation support. | Behavioral: Meditation<br>* Daily meditation<br>* Other names: Expectful App meditation;|
| No Intervention: Control Group<br>Routine lactation support. | |

What is the study measuring?
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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 |