Meditation for NICU Moms

NCT03574766 | Completed

• 1 other identifier: 29082
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Perceived Stress Score:NICU

  Post-intervention/Infant Day of Life # 10

• State-Trait Anxiety Inventory (STAI)

  Post-intervention/Infant Day of Life # 10

• Edinburgh Postnatal Depression Scale (EPDS)

  Post-intervention/Infant Day of Life # 10

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

  Post-intervention/Infant Day of Life # 10

• Salivary Cortisol - Hormonal regulation of breastfeeding and stress response

  Infant Day of Life #9

Study Arms (2)

Meditation Group

EXPERIMENTAL

Twenty minutes of daily meditation for 7 days. Routine lactation support.

Behavioral: Meditation

Control Group

NO INTERVENTION

Routine lactation support.

Interventions

Meditation BEHAVIORAL

Daily meditation

Also known as: Expectful App meditation

Meditation Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Mary's Hospital

Richmond Heights, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Breast Feeding; Premature Birth; Depression, Postpartum; Anxiety Disorders; Behavior; Lactation Disorders

Interventions

Meditation

Condition Hierarchy (Ancestors)

Feeding Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: July 2, 2018
• Study Start: October 17, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

US (1)