Meditation for NICU Moms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- 24 hour breast milk volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 #
- •Inability or unwillingness to perform the study procedures.
结局指标
主要结局
24 hour breast milk volume
时间窗: 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
次要结局
- Edinburgh Postnatal Depression Scale (EPDS)(Post-intervention/Infant Day of Life # 10)
- Sustained breastfeeding at 4 weeks postpartum(4 weeks postpartum)
- State-Trait Anxiety Inventory (STAI)(Post-intervention/Infant Day of Life # 10)
- Use of hand expression - Lactation promoting behaviors(Infant Day of Life #9)
- Pumping episodes -Lactation promoting behaviors(Post-Intervention/Infant Day of Life #9)
- Perceived Stress Score:NICU(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)
- Serum Catecholamines -Hormonal regulation of breastfeeding and stress response(Infant Day of Life #10)
- Number of skin-to-skin episodes -Lactation promoting behaviors(Day of Life #1 through Infant Day of Life #9)
- Salivary Cortisol - Hormonal regulation of breastfeeding and stress response(Infant Day of Life #9)
- Serum Cortisol hormone -Hormonal regulation of breastfeeding and stress response(Infant Day of Life #10)
- Serum Adrenocorticotrophic hormone -Hormonal regulation of breastfeeding and stress response(Infant Day of Life #10)
- Serum Dihydroepiandosterone - Hormonal regulation of breastfeeding and stress response(Infant Day of Life #10)
- Supplementation of infant feeding with formula or donor human breastmilk(4 weeks post-partum)
- Duration of meditation(4 weeks postpartum)
研究者
Katherine Massa, MD
Maternal Fetal Medicine Fellow
St. Louis University