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临床试验/NCT02574871
NCT02574871已完成不适用

Data Collection for Identification of the Chronic Stress Presence in Healthy Adult Subjects

University of Mogi das Cruzes0 个研究点目标入组 120 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
Heart rate variability (HRV)

研究概览

简要总结

This study consists of psychological and biological data collection for identification of the chronic stress presence in healthy adult subjects. The psychological data collected were the results provided by three different instruments: ISSL, PSS and SRRS. The biological data collected were the blood pressure, the skin temperature, the galvanic skin response, and the heart rate variability in time and frequency domain.

详细描述

According to the WHO (World Health Organization) the stress has become a worldwide epidemic and has been considered as the disease of the century, attaining people of different ages and occupations. Stress is defined as a pressure or tension, of a physical, mental or emotional type, which overwhelms the individual and adversely affects the performance of his physical and intellectual functions. When stress is prolonged, the immune system is affected, leaving the body subject to disease and premature aging. Among the psychophysiological reactions associated with excessive stress are chronic fatigue, ulcers, depression, hypertension and heart attack. In light of these consequences, it is important that measures are taken to early identifying the symptoms of stress, allowing people to be properly treated and resume their normal activities.

The studies presented in literature suggest the possibility of using biological signals as indicators of the presence of stress. In these studies, certain physiological variables are measured and related to this stress on the individual. However, most previous studies focused on acute stress, meaning that short-lived. The objective of this study was to relate certain physiological indicators with the presence of chronic stress, ie that long-lasting and often not perceived by the individual.

To this end, the investigators performed the measurement of blood pressure values, skin temperature, galvanic skin response and heart rate variability, and compared with the results provided by the ISSL (Lipp's Inventory of Stress Symptoms for Adults), PSS (Perceived Stress Scale) and SRRS (Social Readjustment Rating Scale), as the stress condition of the individual. The heart rate variability was checked in both time and frequency domain. All of the physiological signals were monitored by non-invasive and non-intrusive sensors and totally safe for participants.

To investigate the relationship between the physiological variables and the existing chronic stress condition the investigators used an algorithm for analysis of biological signals based on Multilayer Perceptron Neural Network with Backpropagation Algorithm (MLP) and Principal Components Analysis (PCA). To evaluate the performance of the classifier on the identification of chronic stress the investigators check the indicators of precision, sensitivity, specificity and accuracy. The results were then analyzed by Receiver Operating Characteristic Curves (ROC).

Ethical approval was obtained from the Local Ethics Committee (CAAE-28201014.2.0000.5497) for the participants. They had been informed about the methodology and confidentiality of their personal information. All procedures were performed after written informed consent from all participants. Data collection was completed in October 2014.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers

排除标准

  • Presence of any disease
  • Use of medications to control blood pressure
  • Use of anxiety medications and antidepressants

结局指标

主要结局

Heart rate variability (HRV)

时间窗: 5 minutes

Short-term heart rate variability recording, according to recommendations of the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology

次要结局

  • Social stress (SRRS)(5 minutes)
  • Perceived stress (PSS)(5 minutes)
  • Galvanic skin response (GSR)(5 minutes)
  • Stress assessment (ISSL)(10 minutes)
  • Temperature measurement (ST)(5 minutes)
  • Blood pressure measurement (BP)(1 minute)

研究者

发起方
University of Mogi das Cruzes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annie France Frère Slaets

PhD

University of Mogi das Cruzes

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