Protocol for a randomized controlled trial comparing phone-based prenatal mindfulness training to usual care for pregnant people at risk for hypertensive disorders of pregnancy

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-08-08 DOI:10.1016/j.cct.2024.107661
Nina K. Ayala , Elena Salmoirago-Blotcher , Ghada Bourjeily , Nicole R. Nugent , Laura Sanapo , Matthias R. Mehl , Margaret Bublitz
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Abstract

Hypertensive disorders of pregnancy (HDP) are the most common medical conditions in pregnancy and a leading cause of maternal morbidity and mortality in the United States. There are few interventions available to prevent HDP, and those currently available do not target underlying mechanisms of disease. Mindfulness training (MT) is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective at blood pressure reduction than other stress management interventions. MT thus holds great promise as a mind-body intervention to prevent HDP. This randomized trial will harness subjective and objective ecological momentary assessment methodology combined with wearable biosensor technology to capture psychological, physiological, and interpersonal processes through which MT may lead to improved maternal cardiovascular parameters. Pregnant women at risk for HDP will be randomized to an 8-week phone-delivered MT intervention or usual care. Through these methods, we will evaluate psychological, physiological, and interpersonal responses to daily experiences linking MT to cardiovascular parameters among women at risk for HDP.

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针对有妊娠高血压疾病风险的孕妇,比较基于电话的产前正念训练和常规护理的随机对照试验方案。
妊娠期高血压疾病(HDP)是妊娠期最常见的疾病,也是美国孕产妇发病和死亡的主要原因。目前可用于预防 HDP 的干预措施很少,而且现有的干预措施并不针对疾病的根本机制。正念训练(MT)能有效降低非妊娠期高血压前期和高血压患者的血压,而且与其他压力管理干预措施相比,正念训练在降低血压方面更有效。因此,正念训练作为预防 HDP 的身心干预措施大有可为。这项随机试验将利用主观和客观生态瞬间评估方法,结合可穿戴生物传感器技术,捕捉心理、生理和人际交往过程,通过这些过程,MT 可改善孕妇的心血管参数。有 HDP 风险的孕妇将随机接受为期 8 周的电话 MT 干预或常规护理。通过这些方法,我们将评估高危孕妇对 MT 与心血管参数相关联的日常体验所产生的心理、生理和人际反应。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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