Meditation for NICU Moms

Anxiety Clinical Trial

Official title:

Meditation for NICU Moms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574766
• Other study ID #: 29082
• Status: Completed
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: December 2020
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Meditation
Daily meditation

Locations

Country	Name	City	State
United States	St. Mary's Hospital	Richmond Heights	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serum Catecholamines -Hormonal regulation of breastfeeding and stress response	Catecholamines during milk expression with meditation versus without meditation.	Infant Day of Life #10
Secondary	Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response	Dihydroepiandosterone during milk expression with meditation versus without meditation.	Infant Day of Life #10
Secondary	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
Secondary	Use of hand expression - Lactation promoting behaviors	Use of hand expression with breastmilk pumping	Infant Day of Life #9
Secondary	Pumping episodes -Lactation promoting behaviors	number of reported pumping episodes reported in 24-hour milk collection log	Post-Intervention/Infant Day of Life #9
Secondary	Supplementation of infant feeding with formula or donor human breastmilk	Supplementation of infant feeding with formula or donor human breastmilk	4 weeks post-partum
Secondary	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
Secondary	Duration of meditation	Duration of meditation at 4 weeks postpartum	4 weeks postpartum