Use of Wearable Devices to Assess the Impact of Stress in Workers' Life Quality
NCT ID: NCT04584021
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
11 participants
OBSERVATIONAL
2019-07-01
2020-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback
NCT06294210
Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place
NCT06814886
Virtual Mindfulness and Breathing Training for Stress, Burnout, Sleep, and Cognition in Rotating-Shift Nurses
NCT07028788
AI-Guided Stress Management Breathing Practices Via a Wearable Device
NCT06881875
Are Personal Smartphones Hurting Work-Life Balance for Nurse Managers?
NCT06343584
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stress study participants
Adults who reported stress problems derived from work
Xiaomi MiBand3
Recording of sleep, activity and heart rate data to study their association with stress.
Socio-demographic questionnaire
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-5L
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)
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)
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)
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 questionnaire
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Xiaomi MiBand3
Recording of sleep, activity and heart rate data to study their association with stress.
Socio-demographic questionnaire
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-5L
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)
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)
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)
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 questionnaire
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center on Information and Communication Technologies
OTHER
Universidade do Porto
OTHER
Universidade da Coruña
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Javier Pereira
Professor PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Javier Pereira, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade da Coruña
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade da Coruña
A Coruña, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Bhui 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.
Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.
Estevez-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.
Hogan 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.
Pignata 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.
Boscolo 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.
Neupert 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.
Aguilar 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.
Gao 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.
Mozos 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.
Bravo 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.
Peake 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.
Nelson 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.
van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, Lloyd A, Scalone L, Kind P, Pickard AS. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012 Jul-Aug;15(5):708-15. doi: 10.1016/j.jval.2012.02.008. Epub 2012 May 24.
Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18.
Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
Hulley, SB, Cummings SR, Browner WS, Grady DG, Newman TB. Designing Clinical Research. Philadelphia: Lippincott Williams & Wilkins; 2014
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019/249
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.