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临床试验/NCT06718907
NCT06718907
招募中
不适用

Mitigating Response to Stressors in the Pregnant Woman

Nova Southeastern University1 个研究点 分布在 1 个国家目标入组 50 人2024年12月20日

概览

阶段
不适用
干预措施
Simulated stimuli
疾病 / 适应症
Pregnancy
发起方
Nova Southeastern University
入组人数
50
试验地点
1
主要终点
Stress level change
状态
招募中
最后更新
2个月前

概览

简要总结

Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.

详细描述

Maternal stress-induced complications are correlated with gestational hypertension, infant low birth weight, and developmental disruption. Various social determinants of health are contributors to stress in pregnant women; factors such as socioeconomic status, education, access to prenatal care, and neighborhood conditions are some of the most identified psychosocial causes of prenatal stress. Further, chronic psychosocial stress is identified as a significant contributor to biophysiological damages such as accelerated telomere shortening in the mother as well as the offspring. Using a public health approach, this research study proposes to gather evidence to assess how response to stress is modulated and how it is captured in and affects pregnant women, with history of prolonged exposure to harmful stressors. More relevant to this study, individuals who have repeated exposure to stressors have poorly managed response to stress and display frequent elevated heart rates due to biological and physiological disruptions. Evidence from the literature suggests that having a support system and utilizing stress management techniques moderate and buffer the effects of stress on physiological measures while facilitating emotional recovery.

注册库
clinicaltrials.gov
开始日期
2024年12月20日
结束日期
2026年12月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

责任方
Sponsor

入排标准

入选标准

  • in 24 weeks gestation or more
  • between 21 and 37 years of age

排除标准

  • in less than 24 weeks gestation
  • high risk pregnancies

研究组 & 干预措施

Stress Exposure and Management

All pregnant participants will be exposed to a 50 second-mild stressful stimulus and a 50 second- relaxant to record physiological responses. The participants will then independently practice easy stress management techniques at home, such as breathing and listening to music. They will do so for one week after the initial data collection.

干预措施: Simulated stimuli

Stress Exposure and Management

All pregnant participants will be exposed to a 50 second-mild stressful stimulus and a 50 second- relaxant to record physiological responses. The participants will then independently practice easy stress management techniques at home, such as breathing and listening to music. They will do so for one week after the initial data collection.

干预措施: Stress Management

结局指标

主要结局

Stress level change

时间窗: 4-8 weeks

change in stress measures as assessed by salivary cortisol levels from collected saliva before and after practicing stress management techniques. Cortisol levels are measured in ug/dL.

研究点 (1)

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