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

October 13, 2020 updated by: Javier Pereira, Universidade da Coruña

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Universidade da Coruña

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress and anxiety level
Time Frame: Until the completion of the study (around 12 months)
Influence of stress and anxiety in the worker
Until the completion of the study (around 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep recording
Time Frame: Until the completion of the study (around 12 months)
Measured by the Xiaomi MiBand3
Until the completion of the study (around 12 months)
Physical activity tracking
Time Frame: Until the completion of the study (around 12 months)
Measured by the Xiaomi MiBand3
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
Measured by the EuroQol-5D-5L scale
At the beginning, mid-term and completion of the study
Sleep habits
Time Frame: At the beginning, mid-term and completion of the study
Measured by the Pittsburgh Sleep Quality Index (PSQI)
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
Measured by the State-Trait Anxiety Inventory (STAI)
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
Measured by the Perceived Stress Scale-10 (PSS-10)
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)
Measured by the stress questionnaire designed by a work stress psychologist professional
Until the completion of the study (around 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Coruña

Collaborators

Universidade do Porto
Center on Information and Communication Technologies

Investigators

  • Principal Investigator: Javier Pereira, PhD, Universidade da Coruña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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