Meditation for NICU Moms

St. Louis University70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Feeding Premature Birth Stress Depression, Postpartum Anxiety

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Post-Intervention/Infant Day of Life #9

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Infant Day of Life #10

Serum Catecholamines -Hormonal regulation of breastfeeding and stress response

Catecholamines during milk expression with meditation versus without meditation.

Time frame: Infant Day of Life #10

Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response

Dihydroepiandosterone during milk expression with meditation versus without meditation.

Time frame: 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

Time frame: Day of Life #1 through Infant Day of Life #9

Use of hand expression - Lactation promoting behaviors

Use of hand expression with breastmilk pumping

Time frame: Infant Day of Life #9

Pumping episodes -Lactation promoting behaviors

number of reported pumping episodes reported in 24-hour milk collection log

Time frame: Post-Intervention/Infant Day of Life #9

Supplementation of infant feeding with formula or donor human breastmilk

Time frame: 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

Time frame: 4 weeks postpartum

Duration of meditation

Duration of meditation at 4 weeks postpartum

Time frame: 4 weeks postpartum

Meditation for NICU Moms

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes