StressNCT02574871
Data Collection for Stress Identification
An observational study of Stress, run by University of Mogi das Cruzes.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Psychological and biological data collection
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: undergraduate students
Who may be able to join
- Healthy volunteers
Who cannot join
- Presence of any disease
- Use of medications to control blood pressure
- Use of anxiety medications and antidepressants
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress
- Being tested
- Psychological and biological data collection
- Keywords
- Stress, Chronic stress, Perceived stress, Psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological and biological data collectionOther
Psychological and biological data collection for identification of the chronic stress presence
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Psychological and biological data collection Receives: Other: Psychological and biological data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
Secondary outcomes (6)
Blood pressure measurement (BP)
Blood pressure measurement of volunteers, according to the guidelines of the Brazilian Society of Cardiology (SBC)
Measured: 1 minute
Temperature measurement (ST)
Skin temperature measurement of volunteers with a digital thermometer
Measured: 5 minutes
Galvanic skin response (GSR)
Galvanic skin response of volunteers recording with a digital GSR recorder
Measured: 5 minutes
Stress assessment (ISSL)
Stress assessment of volunteers, according to the Lipp's Inventory of Stress Symptoms for Adults (ISSL)
Measured: 10 minutes
Perceived stress (PSS)
Perceived stress of volunteers, according to the Perceived Stress Scale (PSS)
Measured: 5 minutes
Social stress (SRRS)
Social stress of volunteers, according to the Social Readjustment Rating Scale (SRRS)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annie France Frère Slaets, University of Mogi das Cruzes
- Investigators
- Annie F Frere Slaets, PhD, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574871
- Sponsor's protocol ID
- 28201014.2.0000.5497
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8598068Zhai 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.
PubMed 17946041Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Holmes 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.
PubMed 6059863Bandeira 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.
PubMed 17164153
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for Identification of the Chronic Stress Presence in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02574871
- Acronym / sponsor ID
- 28201014.2.0000.5497
- Conditions
- Stress
- Keywords
- Stress, Chronic stress, Perceived stress, Psychological distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | Other: Psychological and biological data collectionPsychological and biological data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- undergraduate students
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (3 listed)
- Presence of any disease
- Use of medications to control blood pressure
- Use of anxiety medications and antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological and biological data collectionPsychological and biological data collection for identification of the chronic stress presence | Other | Single Group |
Primary outcome
Heart rate variability (HRV)
Time frame: 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
6 secondary outcomes
Blood pressure measurement (BP)
Time frame: 1 minute
Temperature measurement (ST)
Time frame: 5 minutes
Galvanic skin response (GSR)
Time frame: 5 minutes
Stress assessment (ISSL)
Time frame: 10 minutes
Perceived stress (PSS)
Time frame: 5 minutes
Social stress (SRRS)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 8598068Heart 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.
- Background: PubMed 17946041Zhai 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 6059863Holmes 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.
- Background: PubMed 17164153Bandeira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie F Frere Slaets, PhD principal investigator
University of Mogi das Cruzes
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by University of Mogi das Cruzes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574871, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015; AzTrials last refreshed its copy on 26 Oct 2026.