Back to resultsMeditation for NICU Moms
Primary Purpose
Breast Feeding, Premature Birth, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Feeding
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.
Sites / Locations
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Meditation Group
Control Group
Arm Description
Twenty minutes of daily meditation for 7 days. Routine lactation support.
Routine lactation support.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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)
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.
Salivary Cortisol - Hormonal regulation of breastfeeding and stress response
Diurnal salivary cortisol slope and cortisol awakening response with meditation versus without meditation.
Serum Cortisol hormone -Hormonal regulation of breastfeeding and stress response
Cortisol hormone during milk expression with meditation versus without meditation.
Serum Adrenocorticotrophic hormone -Hormonal regulation of breastfeeding and stress response
Adrenocorticotrophic hormone during milk expression with meditation versus without meditation.
Serum Catecholamines -Hormonal regulation of breastfeeding and stress response
Catecholamines during milk expression with meditation versus without meditation.
Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response
Dihydroepiandosterone during milk expression with meditation versus without meditation.
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
Use of hand expression - Lactation promoting behaviors
Use of hand expression with breastmilk pumping
Pumping episodes -Lactation promoting behaviors
number of reported pumping episodes reported in 24-hour milk collection log
Supplementation of infant feeding with formula or donor human breastmilk
Supplementation of infant feeding with formula or donor human breastmilk
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
Duration of meditation
Duration of meditation at 4 weeks postpartum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03574766
Brief Title
Meditation for NICU Moms
Official Title
Meditation for NICU Moms
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Feeding, Premature Birth, Stress, Depression, Postpartum, Anxiety, Self Efficacy, Behavior, Maternal, Insufficient Lactation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meditation Group
Arm Type
Experimental
Arm Description
Twenty minutes of daily meditation for 7 days. Routine lactation support.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine lactation support.
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Other Intervention Name(s)
Expectful App meditation
Intervention Description
Daily meditation
Primary Outcome Measure Information:
Title
24 hour breast milk volume
Description
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 Outcome Measure Information:
Title
Perceived Stress Score:NICU
Description
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
Title
State-Trait Anxiety Inventory (STAI)
Description
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
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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
Title
Breastfeeding Self-Efficacy Scale-short Form with additional questions for critically ill infants
Description
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
Title
Salivary Cortisol - Hormonal regulation of breastfeeding and stress response
Description
Diurnal salivary cortisol slope and cortisol awakening response with meditation versus without meditation.
Time Frame
Infant Day of Life #9
Title
Serum Cortisol hormone -Hormonal regulation of breastfeeding and stress response
Description
Cortisol hormone during milk expression with meditation versus without meditation.
Time Frame
Infant Day of Life #10
Title
Serum Adrenocorticotrophic hormone -Hormonal regulation of breastfeeding and stress response
Description
Adrenocorticotrophic hormone during milk expression with meditation versus without meditation.
Time Frame
Infant Day of Life #10
Title
Serum Catecholamines -Hormonal regulation of breastfeeding and stress response
Description
Catecholamines during milk expression with meditation versus without meditation.
Time Frame
Infant Day of Life #10
Title
Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response
Description
Dihydroepiandosterone during milk expression with meditation versus without meditation.
Time Frame
Infant Day of Life #10
Title
Number of skin-to-skin episodes -Lactation promoting behaviors
Description
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
Title
Use of hand expression - Lactation promoting behaviors
Description
Use of hand expression with breastmilk pumping
Time Frame
Infant Day of Life #9
Title
Pumping episodes -Lactation promoting behaviors
Description
number of reported pumping episodes reported in 24-hour milk collection log
Time Frame
Post-Intervention/Infant Day of Life #9
Title
Supplementation of infant feeding with formula or donor human breastmilk
Description
Supplementation of infant feeding with formula or donor human breastmilk
Time Frame
4 weeks post-partum
Title
Sustained breastfeeding at 4 weeks postpartum
Description
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
Title
Duration of meditation
Description
Duration of meditation at 4 weeks postpartum
Time Frame
4 weeks postpartum
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
St. Mary's Hospital
City
Richmond Heights
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Meditation for NICU Moms
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