Breast FeedingNCT03574766
Meditation for NICU Moms
A study testing Meditation in people with Breast Feeding and Premature Birth, run by St. Louis University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Premature Birth, Stress
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Mary's Hospital
Richmond Heights, Missouri, 63117
About this study
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.
- Conditions
- Breast Feeding, Premature Birth, Stress, Depression, Postpartum, Anxiety, Self Efficacy
- Being tested
- Meditation
- Medical subject headings
- Breast Feeding, Premature Birth, Depression, Postpartum, Anxiety Disorders, Behavior, Lactation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Also called Expectful App meditation
Daily meditation
| Study group | Role | What they receive |
|---|---|---|
| Meditation Group | Experimental | Twenty minutes of daily meditation for 7 days. Routine lactation support. Receives: Behavioral: Meditation |
| Control Group | No intervention | Routine lactation support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-Intervention/Infant Day of Life #9
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Infant Day of Life #10
Serum Catecholamines -Hormonal regulation of breastfeeding and stress response
Catecholamines during milk expression with meditation versus without meditation.
Measured: Infant Day of Life #10
Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response
Dihydroepiandosterone during milk expression with meditation versus without meditation.
Measured: 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
Measured: Day of Life #1 through Infant Day of Life #9
Use of hand expression - Lactation promoting behaviors
Use of hand expression with breastmilk pumping
Measured: Infant Day of Life #9
Pumping episodes -Lactation promoting behaviors
number of reported pumping episodes reported in 24-hour milk collection log
Measured: 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
Measured: 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
Measured: 4 weeks postpartum
Duration of meditation
Duration of meditation at 4 weeks postpartum
Measured: 4 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start17 Oct 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Massa, MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574766
- Sponsor's protocol ID
- 29082
- Status last verified
- Dec 2020
- First submitted
- 10 May 2018
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation for NICU Moms
- ClinicalTrials.gov ID
- NCT03574766
- Acronym / sponsor ID
- 29082
- Conditions
- Breast Feeding, Premature Birth, Stress, Depression, Postpartum, Anxiety, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Group | Experimental | Behavioral: MeditationTwenty minutes of daily meditation for 7 days. Routine lactation support. |
| Control Group | No intervention | –Routine lactation support. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationAlso: Expectful App meditationDaily meditation | Behavioural | Meditation Group |
Primary outcome
24 hour breast milk volume
Time frame: Post-Intervention/Infant Day of Life #9
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
15 secondary outcomes
Perceived Stress Score:NICU
Time frame: Post-intervention/Infant Day of Life # 10
State-Trait Anxiety Inventory (STAI)
Time frame: Post-intervention/Infant Day of Life # 10
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Post-intervention/Infant Day of Life # 10
Breastfeeding Self-Efficacy Scale-short Form with additional questions for critically ill infants
Time frame: Post-intervention/Infant Day of Life # 10
Salivary Cortisol - Hormonal regulation of breastfeeding and stress response
Time frame: Infant Day of Life #9
Serum Cortisol hormone -Hormonal regulation of breastfeeding and stress response
Time frame: Infant Day of Life #10
Serum Adrenocorticotrophic hormone -Hormonal regulation of breastfeeding and stress response
Time frame: Infant Day of Life #10
Serum Catecholamines -Hormonal regulation of breastfeeding and stress response
Time frame: Infant Day of Life #10
Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response
Time frame: Infant Day of Life #10
Number of skin-to-skin episodes -Lactation promoting behaviors
Time frame: Day of Life #1 through Infant Day of Life #9
Use of hand expression - Lactation promoting behaviors
Time frame: Infant Day of Life #9
Pumping episodes -Lactation promoting behaviors
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
Time frame: 4 weeks postpartum
Duration of meditation
Time frame: 4 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Breast Feeding and Premature Birth, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour breast milk volume (time frame: Post-Intervention/Infant Day of Life #9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.