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Completed

NCT Number: NCT03574766

Meditation for NICU Moms

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.

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Key information

Conditions

Breast Feeding Anxiety Anxiety Disorders Behavior Behavior, Maternal Breast Diseases Depression, Postpartum Depressive Disorder Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Insufficient Lactation Lactation Disorders Mental Disorders Mood Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Puerperal Disorders Self Efficacy Skin Diseases Skin and Connective Tissue Diseases Stress Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Mary's Hospital

Richmond Heights, Missouri, 63117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meditation

Behavioral

Daily meditation

Other names: Expectful App meditation

Primary outcomes

  1. 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

Secondary outcomes

  1. Perceived Stress Score:NICU

    Time frame: Post-intervention/Infant Day of Life # 10

    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.

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: Post-intervention/Infant Day of Life # 10

    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.

  3. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Post-intervention/Infant Day of Life # 10

    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)

  4. Breastfeeding Self-Efficacy Scale-short Form with additional questions for critically ill infants

    Time frame: Post-intervention/Infant Day of Life # 10

    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.

  5. Salivary Cortisol - Hormonal regulation of breastfeeding and stress response

    Time frame: Infant Day of Life #9

    Diurnal salivary cortisol slope and cortisol awakening response with meditation versus without meditation.

  6. Serum Cortisol hormone -Hormonal regulation of breastfeeding and stress response

    Time frame: Infant Day of Life #10

    Cortisol hormone during milk expression with meditation versus without meditation.

  7. Serum Adrenocorticotrophic hormone -Hormonal regulation of breastfeeding and stress response

    Time frame: Infant Day of Life #10

    Adrenocorticotrophic hormone during milk expression with meditation versus without meditation.

  8. Serum Catecholamines -Hormonal regulation of breastfeeding and stress response

    Time frame: Infant Day of Life #10

    Catecholamines during milk expression with meditation versus without meditation.

  9. Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response

    Time frame: Infant Day of Life #10

    Dihydroepiandosterone during milk expression with meditation versus without meditation.

  10. Number of skin-to-skin episodes -Lactation promoting behaviors

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

    Number of skin-to-skin episodes between Infant Day of Life #1 and Infant Day of Life #9 recorded in daily diary

  11. Use of hand expression - Lactation promoting behaviors

    Time frame: Infant Day of Life #9

    Use of hand expression with breastmilk pumping

  12. Pumping episodes -Lactation promoting behaviors

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

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

  13. Supplementation of infant feeding with formula or donor human breastmilk

    Time frame: 4 weeks post-partum

    Supplementation of infant feeding with formula or donor human breastmilk

  14. Sustained breastfeeding at 4 weeks postpartum

    Time frame: 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

  15. Duration of meditation

    Time frame: 4 weeks postpartum

    Duration of meditation at 4 weeks postpartum

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2018
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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