Clinical trial NCT03574766: Meditation for NICU Moms
Official title: Meditation for NICU Moms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Premature Birth
Stress
Depression, Postpartum
Anxiety
Self Efficacy
Behavior, Maternal
Insufficient Lactation
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 24 hour breast milk volume
timeFrame: Post-Intervention/Infant Day of Life #9
Secondary outcomes:
measure: Perceived Stress Score:NICU
timeFrame: Post-intervention/Infant Day of Life # 10
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Post-intervention/Infant Day of Life # 10
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Post-intervention/Infant Day of Life # 10
measure: Breastfeeding Self-Efficacy Scale-short Form with additional questions for critically ill infants
timeFrame: Post-intervention/Infant Day of Life # 10
measure: Salivary Cortisol - Hormonal regulation of breastfeeding and stress response
timeFrame: Infant Day of Life #9
measure: Serum Cortisol hormone -Hormonal regulation of breastfeeding and stress response
timeFrame: Infant Day of Life #10
measure: Serum Adrenocorticotrophic hormone -Hormonal regulation of breastfeeding and stress response
timeFrame: Infant Day of Life #10
measure: Serum Catecholamines -Hormonal regulation of breastfeeding and stress response
timeFrame: Infant Day of Life #10
measure: Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response
timeFrame: Infant Day of Life #10
measure: Number of skin-to-skin episodes -Lactation promoting behaviors
timeFrame: Day of Life #1 through Infant Day of Life #9
measure: Use of hand expression - Lactation promoting behaviors
timeFrame: Infant Day of Life #9
measure: Pumping episodes -Lactation promoting behaviors
timeFrame: Post-Intervention/Infant Day of Life #9
measure: Supplementation of infant feeding with formula or donor human breastmilk
timeFrame: 4 weeks post-partum
measure: Sustained breastfeeding at 4 weeks postpartum
timeFrame: 4 weeks postpartum
measure: Duration of meditation
timeFrame: 4 weeks postpartum
Other outcomes:
Locations:
city: Richmond Heights
country: United States
facility: St. Mary's Hospital
state: Missouri
Study officials:
References: