Data Collection for Stress Identification

Completed

• Conditions: Stress
• Interventions: Other: Psychological and biological data collection

• Registration Number: NCT02574871
• Lead Sponsor: University of Mogi das Cruzes

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-10
• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-13
• Last Update Submitted: 2015-10-13
• Study First Posted: 2015-10-14
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Group	Psychological and biological data collection	Psychological and biological data collection

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV)	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

Secondary Outcome Measures

Name	Time	Method
Social stress (SRRS)	5 minutes	Social stress of volunteers, according to the Social Readjustment Rating Scale (SRRS)
Perceived stress (PSS)	5 minutes	Perceived stress of volunteers, according to the Perceived Stress Scale (PSS)
Galvanic skin response (GSR)	5 minutes	Galvanic skin response of volunteers recording with a digital GSR recorder
Stress assessment (ISSL)	10 minutes	Stress assessment of volunteers, according to the Lipp's Inventory of Stress Symptoms for Adults (ISSL)
Temperature measurement (ST)	5 minutes	Skin temperature measurement of volunteers with a digital thermometer
Blood pressure measurement (BP)	1 minute	Blood pressure measurement of volunteers, according to the guidelines of the Brazilian Society of Cardiology (SBC)