NCT05087329终止不适用
Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Decrease in Maternal Stress
研究概览
简要总结
The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 16w0d-26w6d gestation with a single gestation who have had a confirmed dating ultrasound
- •a. Only women with singleton gestations will be included because multiple gestation pregnancies introduce additional levels of stress and introduce confounding variables for the adverse composite pregnancy outcome that will be measured. As this is a study of pregnant patients, only women are included.
- •English speaking
- •a. The mindfulness meditation trainings have been scripted and recorded in English. Thus, to understand the recordings and participate in the courses it is necessary for all participants to speak English.
- •Regular internet access through either phone, tablet or computer. a. Mindfulness meditations are administered via Zoom webinars so internet access is required. A proxy for internet access during recruitment will be confirmed by the inclusion of an email address in the electronic medical record (EMR).
排除标准
- •Multiple gestations. This has been chosen as an exclusion criteria to limit confounding variables for the secondary outcome of composite adverse pregnancy events.
研究组 & 干预措施
Virtual Mindfulness intervention
Experimental
Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation
干预措施: Virtual Mindfulness Meditation (Behavioral)
Standard of Care
No Intervention
结局指标
主要结局
Decrease in Maternal Stress
时间窗: 6 to 8 weeks
Change in score on Perceived Stress Scale (PSS)
次要结局
- Composite score of maternal morbidity/pregnancy outcomes(6 to 8 weeks post-delivery)
- Change in score on Edinburgh Postnatal Depression Scale(change between score at time of delivery and 6 weeks)
研究者
Kirstin Leitner
Assitant Professor of Obstetrics and Gynecology
University of Pennsylvania
研究点 (1)
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