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临床试验/NCT03679117
NCT03679117已完成不适用

Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension

Lifespan2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Lifespan
入组人数
30
试验地点
2
主要终点
Retention and Adherence

研究概览

简要总结

Hypertensive disorders of pregnancy are one of the greatest causes of death to mothers and babies. These disorders affect 1 out of every 10 pregnancies, the rate is increasing in the United States, and rate of recurrence is as high as 50%. Treatments to prevent hypertensive disorders of pregnancy from happening in future pregnancies are limited. There are currently no effective interventions to prevent hypertension recurrence in pregnancy that do not involve medications.

Mindfulness interventions hold great potential as a medication-free approach to prevent the recurrence of hypertension in pregnant women with histories of hypertensive disorders. However, traditional group-based mindfulness training interventions, requiring 2.5 hours of class attendance for 8 weeks plus a full-day retreat, are very difficult for pregnant women with medical conditions to attend.

The goal of the current study is to determine if phone-delivered mindfulness training is an acceptable intervention among pregnant women with histories of hypertensive disorders of pregnancy. 20 pregnant women with histories of hypertensive disorders of pregnancy will be randomly picked to participate in an 8-week phone-delivered mindfulness training intervention (N=10) or usual care (N=10). All women will undergo blood pressure monitoring before and after the intervention. The investigators predict that phone-delivered mindfulness training will reduce risk for hypertension recurrence.

详细描述

Hypertensive disorders of pregnancy are one of the greatest causes of perinatal morbidity and mortality. Hypertensive disorders of pregnancy affect 1 out of every 10 pregnancies, the rate has increased substantially over the past several decades, and rates of recurrence are as high as 50%. Treatments to prevent the recurrence of hypertension are extremely limited and include watchful waiting, anti-hypertensive medications, or ultimately, early delivery. There are currently no effective alternatives to pharmacological interventions to prevent hypertension recurrence in pregnancy.

Mindfulness interventions hold great potential as a non-pharmacological approach to reduce stress and prevent the recurrence of hypertension in pregnant women with histories of hypertensive disorders. However, traditional group-based mindfulness training interventions, requiring 2.5 hours of class attendance for 8 weeks plus a full-day retreat, are infeasible in pregnancies complicated by hypertensive disorders due to the need for activity restriction, hospitalization, and increased maternal and fetal monitoring.

The goal of the current study is to determine if phone-delivered mindfulness training is feasible and acceptable among pregnant women with histories of hypertensive disorders of pregnancy. 20 pregnant women with histories of hypertensive disorders of pregnancy will be randomized to an 8-week phone-delivered mindfulness training intervention (N=10) or usual care (N=10). All women will undergo 24-hour ambulatory blood pressure monitoring before and after the intervention. The investigators will used a mixed-methods approach using both quantitative and qualitative data to examine feasibility/acceptability. The working hypothesis, to be tested in a fully-powered randomized controlled trial, is that phone-delivered mindfulness training will reduce risk for hypertension recurrence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • > 18 years old,
  • Singleton pregnancy,
  • English speaking,
  • <20 weeks' gestation at enrollment,
  • History of a hypertensive disorder in a prior pregnancy.

排除标准

  • No current engagement in mindfulness training (defined as weekly yoga, mindfulness exercises (including on-line), or meditation).

结局指标

主要结局

Retention and Adherence

时间窗: Through study completion, an average of 20 weeks

Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.

次要结局

  • Hypertension Diagnosis(Through study completion, an average of 20 weeks)

研究者

发起方
Lifespan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Bublitz

Research Scientist

Lifespan

研究点 (2)

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