Stress DisorderSQoF-WEARNCT04584021
Use of Wearable Devices to Assess the Impact of Stress in Workers' Life Quality
An observational study of Stress Disorder and Burnout, Professional, run by Universidade da Coruña at 1 site in Spain.
Trial summary
Introduction: Work stress has become more and more important in the last years as it affects both health and productivity of workers. In the last years, different wearables devices have started to be used to monitor stress at work to understand their consequences on daily life activity and sleep quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorder, Burnout, Professional, Sleep Disorder
- What is being tested?
- Xiaomi MiBand3, Socio-demographic questionnaire and EuroQol-5D-5L
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to 1 Jul 2020
- 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
- Adult, Older adult
Study population: Working population in a research center, who accept and consent to participate in a stress project.
Who may be able to join
- To be developing their professional activity in a research center
Who cannot join
- To be close to retirement (5 years or less)
- To have significant health condition complications that difficult active participation in the study
- To present hypersensitivity in the skin or a recognized allergy to the material of which are made the cases or straps of the wearable wristbands to be used as one of the measuring instruments of the study are made.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Project Based on the Use of Wearable Devices to Assess the Impact of Stress in the Work Environment on the Quality of Life of Workers: Project SQoF-WEAR
Introduction: Work stress has become more and more important in the last years as it affects both health and productivity of workers. In the last years, different wearables devices have started to be used to monitor stress at work to understand their consequences on daily life activity and sleep quality.
Objective: to establish whether wearable wristbands are devices capable of determining the work stress level of workers from a research center in Galicia, for which different variables related to the work stress level and quality of life of these workers will be evaluated.
Read more
Methods and analysis: The only inclusion criterion is to be a worker from a research center from Galicia. As for exclusion criteria, will not be allowed to participate those workers who are close to retirement ( <5 years), have health issues that hinder participation in the study, or present skin hypersensitivity or allergic reactions due to the materials the wristbands are made.
This is a pilot study to determine the viability, sample size, cost, and duration of the study. This is an observational, analytic, and longitudinal study. In other words, in this study different variables from the population of interest will be observed and recorded without any direct intervention, so as to establish causality associations between these variables. It is considered as longitudinal since a six-months tracking of the variables will be performed.
As for the statistical analysis, different tests will be performed to analyse the distribution, correlation, and association of the different features, as well as the significant differences between them at different points of the study (detailed below).
Read the detailed description
Introduction: Stress is a natural phenomenon within the human body that prepares the organism for action. However, due to the current life and work habits and demands, stress goes beyond what is beneficial and starts to suppose a burden. Nowadays, work stress, which is defined as "a harmful reaction, which people have to deal with, to the pressures and undue demands placed on them at work", has gained importance as it affects both health and productivity of workers. If stress persists over time, it can lead to the syndrome known as Burnout, which implies deep exhaustion, and inefficiency. In the last years, different wearable devices have started to be used to monitor stress at work with the aim of understanding their consequences on physical activity and sleep quality.
Objective: To establish whether wearable wristbands are devices capable of determining the work stress level of workers from a research center in Galicia. To this end, it will be determined the work stress level and quality of life of these workers to conclude if the devices measure the work stress with precision. Also, different physical activity, sleep and occupational functioning patterns will be identified to study the relation between them and the work stress level and quality of life.
Methods and Analysis: The study will be carried out with workers from a research center from Galicia, being this the only inclusion criterion. As for exclusion criteria, workers will not be allowed to participate if they are expected to retire in a period of 5 years or less, have significant health issues that hinder the participation in the study, or present skin hypersensitivity or allergic reactions caused by the materials the wristbands are made of.
This is a pilot study to determine the viability, sample size, cost, and duration of the study. Likewise, a pilot project has also been designed in this study in order to "demonstrate that the planned measurements, the data collection instruments and the data management system are feasible and effective". This is an observational, analytical, and longitudinal study. That is, in this study different variables of the population under study will be observed and recorded without intervention and with the aim of establishing causal associations between variables. It is considered longitudinal because variables will be followed for 6 months, continuously recording and monitoring physical activity and the quality of sleep (wristbands), and in a specific way, variables related to work stress, quality of life, and perception of the quality of sleep and the level of physical activity (specific evaluation tools).
As for the statistical analysis, and once the data are preprocessed, for the collected variables the Kolmogorov-Smirnov will be applied to check if they behave as a normal distribution. Otherwise, posterior analysis with non-parametric tests will be performed. The correlation of the numeric variables will be analysed through the Pearson or Spearman's Rho correlation depending on the sample distribution. A Chi-Square test will be used to assess the association between categoric variables unless the observed frequencies are <5%, for which a likelihood ratio test would be used. Regarding the association between quantitative and qualitative variables, the mean comparison with a T and ANOVA test, or a Mann Whitney and Kruskal Wallis test, as appropriate, will be performed. To finish, with the aim of determining whether there are significant differences between the results of the beginning, mid-term and final evaluations, a Wilcoxon test will be applied.
- Being tested
- Xiaomi MiBand3, Socio-demographic questionnaire, EuroQol-5D-5L, Pittsburgh Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI)
- Keywords
- Stress Disorder, Burnout, Participatory Health, Quality of life, Daily functioning
- Medical subject headings
- Stress Disorders, Traumatic, Burnout, Professional, Sleep Wake Disorders, Anxiety Disorders, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaomi MiBand3Device
Recording of sleep, activity and heart rate data to study their association with stress.
Socio-demographic questionnaireOther
Self-made questionnaire to be filled by the participants at the beginning of the study with the following personal data: age, gender, marital status, residential environment, cohabitation unit, educational level, socio-economic level, contract, working hours, overtime or not, number of overtime hours in a day, overtime frequency and perceived stress level
EuroQol-5D-5LOther
Quality of life questionnaire to be filled by the participants at the beginning, mid-term and completion of the study with the following information: severity index, social value index for each health condition. Subjective evaluation of health status from 0 to 100.
Pittsburgh Sleep Quality Index (PSQI)Other
Questionnaire to be filled by the participants whose outcome is the perceived quality, quantity and efficient of sleep. To be given at the beginning, mid-term, and completion of the study.
State-Trait Anxiety Inventory (STAI)Other
Questionnaire to be filled by the participants which measures the anxiety level. To be given at the beginning, mid-term and completion of the study.
Perceived Stress Scale-10 (PSS-10)Other
Questionnaire to be filled by the participants which measures the stress level. To be given at the beginning, mid-term and completion of the study.
Stress questionnaireOther
Questionnaire designed by a work stress psychologist professional from the research group which is focused on stress and daily functioning. This questionnaire was given for the participants to fill. It is composed by 3 daily items and 4 weekly items.
| Study group | Role | What they receive |
|---|---|---|
| Stress study participants | Adults who reported stress problems derived from work Receives: Device: Xiaomi MiBand3; Other: Socio-demographic questionnaire; Other: EuroQol-5D-5L; Other: Pittsburgh Sleep Quality Index (PSQI); Other: State-Trait Anxiety Inventory (STAI); Other: Perceived Stress Scale-10 (PSS-10); Other: Stress questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress and anxiety level
Influence of stress and anxiety in the worker
Measured: Until the completion of the study (around 12 months)
Secondary outcomes (7)
Sleep recording
Measured by the Xiaomi MiBand3
Measured: Until the completion of the study (around 12 months)
Physical activity tracking
Measured by the Xiaomi MiBand3
Measured: Until the completion of the study (around 12 months)
Quality of life self-perception
Measured by the EuroQol-5D-5L scale
Measured: At the beginning, mid-term and completion of the study
Sleep habits
Measured by the Pittsburgh Sleep Quality Index (PSQI)
Measured: At the beginning, mid-term and completion of the study
Anxiety self-perception
Measured by the State-Trait Anxiety Inventory (STAI)
Measured: At the beginning, mid-term and completion of the study
Stress self-perception
Measured by the Perceived Stress Scale-10 (PSS-10)
Measured: At the beginning, mid-term and completion of the study
Stress influence on daily functioning
Measured by the stress questionnaire designed by a work stress psychologist professional
Measured: Until the completion of the study (around 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Stress DisorderStudies 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
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Center on Information and Communication Technologies, Universidade do Porto
- Responsible party
- Principal investigator, Javier Pereira, Universidade da Coruña
- Investigators
- Javier Pereira, PhD, Principal investigator, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584021
- Sponsor's protocol ID
- 2019/249
- Acronym
- SQoF-WEAR
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Almeida DM. Resilience and vulnerability to daily stressors assessed via diary methods. Curr Dir Psychol Sci. 2005 Apr 1;14(2):64-8
Almeida DM, Wethington E, Kessler RC. The daily inventory of stressful events: an interview-based approach for measuring daily stressors. Assessment. 2002 Mar;9(1):41-55. doi: 10.1177/1073191102091006.
PubMed 11911234Bhui K, Dinos S, Galant-Miecznikowska M, de Jongh B, Stansfeld S. Perceptions of work stress causes and effective interventions in employees working in public, private and non-governmental organisations: a qualitative study. BJPsych Bull. 2016 Dec;40(6):318-325. doi: 10.1192/pb.bp.115.050823.
PubMed 28377811Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.
PubMed 11148311Estevez-Mujica CP, Quintane E. E-mail communication patterns and job burnout. PLoS One. 2018 Mar 8;13(3):e0193966. doi: 10.1371/journal.pone.0193966. eCollection 2018.
PubMed 29518128Hogan V, Hogan M, Hodgins M. A study of workaholism in Irish academics. Occup Med (Lond). 2016 Aug;66(6):460-5. doi: 10.1093/occmed/kqw032. Epub 2016 May 11.
PubMed 27170737Pignata S, Winefield AH. Stress-reduction interventions in an Australian university: a case study. Stress Health. 2015 Feb;31(1):24-34. doi: 10.1002/smi.2517. Epub 2013 Jul 23.
PubMed 23878071Boscolo P, Di Donato A, Di Giampaolo L, Forcella L, Reale M, Dadorante V, Alparone F, Pagliaro S, Kouri M, Magrini A, Fattorini E. Blood natural killer activity is reduced in men with occupational stress and job insecurity working in a university. Int Arch Occup Environ Health. 2009 May;82(6):787-94. doi: 10.1007/s00420-008-0374-5. Epub 2008 Oct 22.
PubMed 18941771Neupert SD, Almeida DM, Mroczek DK, Spiro A 3rd. Daily stressors and memory failures in a naturalistic setting: findings from the VA Normative Aging Study. Psychol Aging. 2006 Jun;21(2):424-9. doi: 10.1037/0882-7974.21.2.424.
PubMed 16768588Aguilar Cordero MJ, Sanchez Lopez AM, Mur Villar N, Garcia Garcia I, Rodriguez Lopez MA, Ortegon Pinero A, Cortes Castell E. [Salivary cortisol as an indicator of physological stress in children and adults; a systematic review]. Nutr Hosp. 2014 May 1;29(5):960-8. doi: 10.3305/nh.2014.29.5.7273. Spanish.
PubMed 24951973Gao W, Brooks GA, Klonoff DC. Wearable physiological systems and technologies for metabolic monitoring. J Appl Physiol (1985). 2018 Mar 1;124(3):548-556. doi: 10.1152/japplphysiol.00407.2017. Epub 2017 Sep 28.
PubMed 28970200Mozos OM, Sandulescu V, Andrews S, Ellis D, Bellotto N, Dobrescu R, Ferrandez JM. Stress Detection Using Wearable Physiological and Sociometric Sensors. Int J Neural Syst. 2017 Mar;27(2):1650041. doi: 10.1142/S0129065716500416. Epub 2016 May 16.
PubMed 27440466Bravo P, Contreras A, Perestelo-Perez L, Perez-Ramos J, Malaga G. [Looking for a more participative healthcare: sharing medical decision making]. Rev Peru Med Exp Salud Publica. 2013 Oct-Dec;30(4):691-7. Spanish.
PubMed 24448951Peake JM, Kerr G, Sullivan JP. A Critical Review of Consumer Wearables, Mobile Applications, and Equipment for Providing Biofeedback, Monitoring Stress, and Sleep in Physically Active Populations. Front Physiol. 2018 Jun 28;9:743. doi: 10.3389/fphys.2018.00743. eCollection 2018.
PubMed 30002629Nelson MB, Kaminsky LA, Dickin DC, Montoye AH. Validity of Consumer-Based Physical Activity Monitors for Specific Activity Types. Med Sci Sports Exerc. 2016 Aug;48(8):1619-28. doi: 10.1249/MSS.0000000000000933.
PubMed 27015387
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project Based on the Use of Wearable Devices to Assess the Impact of Stress in the Work Environment on the Quality of Life of Workers: Project SQoF-WEAR
- ClinicalTrials.gov ID
- NCT04584021
- Acronym / sponsor ID
- SQoF-WEAR / 2019/249
- Keywords
- Stress Disorder, Burnout, Participatory Health, Quality of life, Daily functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Center on Information and Communication Technologies, Universidade do Porto
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 12 Oct 2020 (actual)
- 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.
Introduction: Work stress has become more and more important in the last years as it affects both health and productivity of workers. In the last years, different wearables devices have started to be used to monitor stress at work to understand their consequences on daily life activity and sleep quality.
Objective: to establish whether wearable wristbands are devices capable of determining the work stress level of workers from a research center in Galicia, for which different variables related to the work stress level and quality of life of these workers will be evaluated.
Methods and analysis: The only inclusion criterion is to be a worker from a research center from Galicia. As for exclusion criteria, will not be allowed to participate those workers who are close to retirement ( <5 years), have health issues that hinder participation in the study, or present skin hypersensitivity or allergic reactions due to the materials the wristbands are made.
This is a pilot study to determine the viability, sample size, cost, and duration of the study. This is an observational, analytic, and longitudinal study. In other words, in this study different variables from the population of interest will be observed and recorded without any direct intervention, so as to establish causality associations between these variables. It is considered as longitudinal since a six-months tracking of the variables will be performed.
As for the statistical analysis, different tests will be performed to analyse the distribution, correlation, and association of the different features, as well as the significant differences between them at different points of the study (detailed below).
Detailed description
Introduction: Stress is a natural phenomenon within the human body that prepares the organism for action. However, due to the current life and work habits and demands, stress goes beyond what is beneficial and starts to suppose a burden. Nowadays, work stress, which is defined as "a harmful reaction, which people have to deal with, to the pressures and undue demands placed on them at work", has gained importance as it affects both health and productivity of workers. If stress persists over time, it can lead to the syndrome known as Burnout, which implies deep exhaustion, and inefficiency. In the last years, different wearable devices have started to be used to monitor stress at work with the aim of understanding their consequences on physical activity and sleep quality.
Objective: To establish whether wearable wristbands are devices capable of determining the work stress level of workers from a research center in Galicia. To this end, it will be determined the work stress level and quality of life of these workers to conclude if the devices measure the work stress with precision. Also, different physical activity, sleep and occupational functioning patterns will be identified to study the relation between them and the work stress level and quality of life.
Methods and Analysis: The study will be carried out with workers from a research center from Galicia, being this the only inclusion criterion. As for exclusion criteria, workers will not be allowed to participate if they are expected to retire in a period of 5 years or less, have significant health issues that hinder the participation in the study, or present skin hypersensitivity or allergic reactions caused by the materials the wristbands are made of.
This is a pilot study to determine the viability, sample size, cost, and duration of the study. Likewise, a pilot project has also been designed in this study in order to "demonstrate that the planned measurements, the data collection instruments and the data management system are feasible and effective". This is an observational, analytical, and longitudinal study. That is, in this study different variables of the population under study will be observed and recorded without intervention and with the aim of establishing causal associations between variables. It is considered longitudinal because variables will be followed for 6 months, continuously recording and monitoring physical activity and the quality of sleep (wristbands), and in a specific way, variables related to work stress, quality of life, and perception of the quality of sleep and the level of physical activity (specific evaluation tools).
As for the statistical analysis, and once the data are preprocessed, for the collected variables the Kolmogorov-Smirnov will be applied to check if they behave as a normal distribution. Otherwise, posterior analysis with non-parametric tests will be performed. The correlation of the numeric variables will be analysed through the Pearson or Spearman's Rho correlation depending on the sample distribution. A Chi-Square test will be used to assess the association between categoric variables unless the observed frequencies are <5%, for which a likelihood ratio test would be used. Regarding the association between quantitative and qualitative variables, the mean comparison with a T and ANOVA test, or a Mann Whitney and Kruskal Wallis test, as appropriate, will be performed. To finish, with the aim of determining whether there are significant differences between the results of the beginning, mid-term and final evaluations, a Wilcoxon test will be applied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress study participants | – | Device: Xiaomi MiBand3, Other: Socio-demographic questionnaire, Other: EuroQol-5D-5L, Other: Pittsburgh Sleep Quality Index (PSQI), Other: State-Trait Anxiety Inventory (STAI), Other: Perceived Stress Scale-10 (PSS-10), Other: Stress questionnaireAdults who reported stress problems derived from work |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Working population in a research center, who accept and consent to participate in a stress project.
Key inclusion criteria (1 listed)
- To be developing their professional activity in a research center
Key exclusion criteria (3 listed)
- To be close to retirement (5 years or less)
- To have significant health condition complications that difficult active participation in the study
- To present hypersensitivity in the skin or a recognized allergy to the material of which are made the cases or straps of the wearable wristbands to be used as one of the measuring instruments of the study are made.
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 |
|---|---|---|
| Xiaomi MiBand3Recording of sleep, activity and heart rate data to study their association with stress. | Device | Stress study participants |
| Socio-demographic questionnaireSelf-made questionnaire to be filled by the participants at the beginning of the study with the following personal data: age, gender, marital status, residential environment, cohabitation unit, educational level, socio-economic level, contract, working hours, overtime or not, number of overtime hours in a day, overtime frequency and perceived stress level | Other | Stress study participants |
| EuroQol-5D-5LQuality of life questionnaire to be filled by the participants at the beginning, mid-term and completion of the study with the following information: severity index, social value index for each health condition. Subjective evaluation of health status from 0 to 100. | Other | Stress study participants |
| Pittsburgh Sleep Quality Index (PSQI)Questionnaire to be filled by the participants whose outcome is the perceived quality, quantity and efficient of sleep. To be given at the beginning, mid-term, and completion of the study. | Other | Stress study participants |
| State-Trait Anxiety Inventory (STAI)Questionnaire to be filled by the participants which measures the anxiety level. To be given at the beginning, mid-term and completion of the study. | Other | Stress study participants |
| Perceived Stress Scale-10 (PSS-10)Questionnaire to be filled by the participants which measures the stress level. To be given at the beginning, mid-term and completion of the study. | Other | Stress study participants |
| Stress questionnaireQuestionnaire designed by a work stress psychologist professional from the research group which is focused on stress and daily functioning. This questionnaire was given for the participants to fill. It is composed by 3 daily items and 4 weekly items. | Other | Stress study participants |
Primary outcome
Stress and anxiety level
Time frame: Until the completion of the study (around 12 months)
Influence of stress and anxiety in the worker
7 secondary outcomes
Sleep recording
Time frame: Until the completion of the study (around 12 months)
Physical activity tracking
Time frame: Until the completion of the study (around 12 months)
Quality of life self-perception
Time frame: At the beginning, mid-term and completion of the study
Sleep habits
Time frame: At the beginning, mid-term and completion of the study
Anxiety self-perception
Time frame: At the beginning, mid-term and completion of the study
Stress self-perception
Time frame: At the beginning, mid-term and completion of the study
Stress influence on daily functioning
Time frame: Until the completion of the study (around 12 months)
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 19 Oct 2020.
- BackgroundAlmeida DM. Resilience and vulnerability to daily stressors assessed via diary methods. Curr Dir Psychol Sci. 2005 Apr 1;14(2):64-8
- Background: PubMed 11911234Almeida DM, Wethington E, Kessler RC. The daily inventory of stressful events: an interview-based approach for measuring daily stressors. Assessment. 2002 Mar;9(1):41-55. doi: 10.1177/1073191102091006.
- Background: PubMed 28377811Bhui K, Dinos S, Galant-Miecznikowska M, de Jongh B, Stansfeld S. Perceptions of work stress causes and effective interventions in employees working in public, private and non-governmental organisations: a qualitative study. BJPsych Bull. 2016 Dec;40(6):318-325. doi: 10.1192/pb.bp.115.050823.
- Background: PubMed 11148311Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.
- Background: PubMed 29518128Estevez-Mujica CP, Quintane E. E-mail communication patterns and job burnout. PLoS One. 2018 Mar 8;13(3):e0193966. doi: 10.1371/journal.pone.0193966. eCollection 2018.
- Background: PubMed 27170737Hogan V, Hogan M, Hodgins M. A study of workaholism in Irish academics. Occup Med (Lond). 2016 Aug;66(6):460-5. doi: 10.1093/occmed/kqw032. Epub 2016 May 11.
- Background: PubMed 23878071Pignata S, Winefield AH. Stress-reduction interventions in an Australian university: a case study. Stress Health. 2015 Feb;31(1):24-34. doi: 10.1002/smi.2517. Epub 2013 Jul 23.
- Background: PubMed 18941771Boscolo P, Di Donato A, Di Giampaolo L, Forcella L, Reale M, Dadorante V, Alparone F, Pagliaro S, Kouri M, Magrini A, Fattorini E. Blood natural killer activity is reduced in men with occupational stress and job insecurity working in a university. Int Arch Occup Environ Health. 2009 May;82(6):787-94. doi: 10.1007/s00420-008-0374-5. Epub 2008 Oct 22.
- Background: PubMed 16768588Neupert SD, Almeida DM, Mroczek DK, Spiro A 3rd. Daily stressors and memory failures in a naturalistic setting: findings from the VA Normative Aging Study. Psychol Aging. 2006 Jun;21(2):424-9. doi: 10.1037/0882-7974.21.2.424.
- Background: PubMed 24951973Aguilar Cordero MJ, Sanchez Lopez AM, Mur Villar N, Garcia Garcia I, Rodriguez Lopez MA, Ortegon Pinero A, Cortes Castell E. [Salivary cortisol as an indicator of physological stress in children and adults; a systematic review]. Nutr Hosp. 2014 May 1;29(5):960-8. doi: 10.3305/nh.2014.29.5.7273. Spanish.
- Background: PubMed 28970200Gao W, Brooks GA, Klonoff DC. Wearable physiological systems and technologies for metabolic monitoring. J Appl Physiol (1985). 2018 Mar 1;124(3):548-556. doi: 10.1152/japplphysiol.00407.2017. Epub 2017 Sep 28.
- Background: PubMed 27440466Mozos OM, Sandulescu V, Andrews S, Ellis D, Bellotto N, Dobrescu R, Ferrandez JM. Stress Detection Using Wearable Physiological and Sociometric Sensors. Int J Neural Syst. 2017 Mar;27(2):1650041. doi: 10.1142/S0129065716500416. Epub 2016 May 16.
- Individual participant dataSharing planned: Undecided
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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.
Javier Pereira, PhD principal investigator
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorder and Burnout, Professional, run by Universidade da Coruña at 1 site in Spain.
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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Stress and anxiety level (time frame: Until the completion of the study (around 12 months)). 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 NCT04584021, which also lists 19 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 19 Oct 2020.