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Use of Wearable Devices to Assess the Impact of Stress in Workers' Life Quality (SQoF-WEAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584021
Recruitment Status : Completed
First Posted : October 12, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Center on Information and Communication Technologies
Universidade do Porto
Information provided by (Responsible Party):
Javier Pereira, Universidade da Coruña

Brief 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.

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).


Condition or disease Intervention/treatment
Stress Disorder Burnout, Professional Sleep Disorder Quality of Life Anxiety State 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

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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Stress study participants
Adults who reported stress problems derived from work
Device: Xiaomi MiBand3
Recording of sleep, activity and heart rate data to study their association with stress.

Other: 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

Other: 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.

Other: 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: 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: 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 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.




Primary Outcome Measures :
  1. Stress and anxiety level [ Time Frame: Until the completion of the study (around 12 months) ]
    Influence of stress and anxiety in the worker


Secondary Outcome Measures :
  1. Sleep recording [ Time Frame: Until the completion of the study (around 12 months) ]
    Measured by the Xiaomi MiBand3

  2. Physical activity tracking [ Time Frame: Until the completion of the study (around 12 months) ]
    Measured by the Xiaomi MiBand3

  3. Quality of life self-perception [ Time Frame: At the beginning, mid-term and completion of the study ]
    Measured by the EuroQol-5D-5L scale

  4. Sleep habits [ Time Frame: At the beginning, mid-term and completion of the study ]
    Measured by the Pittsburgh Sleep Quality Index (PSQI)

  5. Anxiety self-perception [ Time Frame: At the beginning, mid-term and completion of the study ]
    Measured by the State-Trait Anxiety Inventory (STAI)

  6. Stress self-perception [ Time Frame: At the beginning, mid-term and completion of the study ]
    Measured by the Perceived Stress Scale-10 (PSS-10)

  7. Stress influence on daily functioning [ Time Frame: Until the completion of the study (around 12 months) ]
    Measured by the stress questionnaire designed by a work stress psychologist professional



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Working population in a research center, who accept and consent to participate in a stress project.
Criteria

Inclusion Criteria:

  • To be developing their professional activity in a research center

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584021


Locations
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Spain
Universidade da Coruña
A Coruña, Spain, 15006
Sponsors and Collaborators
Universidade da Coruña
Center on Information and Communication Technologies
Universidade do Porto
Investigators
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Principal Investigator: Javier Pereira, PhD Universidade da Coruña
Publications:
Almeida DM. Resilience and vulnerability to daily stressors assessed via diary methods. Curr Dir Psychol Sci. 2005 Apr 1;14(2):64-8
Hulley, SB, Cummings SR, Browner WS, Grady DG, Newman TB. Designing Clinical Research. Philadelphia: Lippincott Williams & Wilkins; 2014

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Responsible Party: Javier Pereira, Professor PhD, Universidade da Coruña
ClinicalTrials.gov Identifier: NCT04584021    
Other Study ID Numbers: 2019/249
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier Pereira, Universidade da Coruña:
Stress Disorder
Burnout
Participatory Health
Quality of life
Daily functioning
Additional relevant MeSH terms:
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Sleep Wake Disorders
Disease
Burnout, Professional
Stress Disorders, Traumatic
Burnout, Psychological
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases