Data Collection for Stress Identification

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

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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Other: Psychological and biological data collection

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 Type: Observational
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

undergraduate students

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Group; Psychological and biological data collection	Other: Psychological and biological data collection; Psychological and biological data collection for identification of the chronic stress presence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability (HRV)	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	5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Mogi das Cruzes
• Investigators: Principal Investigator: Annie F Frere Slaets, PhD, University of Mogi das Cruzes

Publications and helpful links

General Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
• Zhai J, Barreto A. Stress detection in computer users based on digital signal processing of noninvasive physiological variables. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:1355-8. doi: 10.1109/IEMBS.2006.259421.
• Holmes TH, Rahe RH. The Social Readjustment Rating Scale. J Psychosom Res. 1967 Aug;11(2):213-8. doi: 10.1016/0022-3999(67)90010-4. No abstract available.
• Bandeira DR, Pawlowski J, Goncalves TR, Hilgert JB, Bozzetti MC, Hugo FN. Psychological distress in Brazilian caregivers of relatives with dementia. Aging Ment Health. 2007 Jan;11(1):14-9. doi: 10.1080/13607860600640814.

Helpful Links

• Guidelines of the Brazilian Society of Cardiology

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Stress; Chronic stress; Perceived stress; Psychological distress
• Other Study ID Numbers: 28201014.2.0000.5497

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No