Use of Wearable Devices to Assess the Impact of Stress in Workers' Life Quality

NCT04584021 | Completed

• 1 other identifier: 2019/249
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Disorder; Burnout, Professional; Sleep Disorder; Quality of Life; Anxiety State

Keywords

Stress Disorder; Burnout; Participatory Health; Quality of life; Daily functioning

Outcome Measures

Primary Outcomes (1)

• Stress and anxiety level

  Influence of stress and anxiety in the worker

  Until the completion of the study (around 12 months)

Secondary Outcomes (7)

• Sleep recording

  Until the completion of the study (around 12 months)

• Physical activity tracking

  Until the completion of the study (around 12 months)

• Quality of life self-perception

  At the beginning, mid-term and completion of the study

• Sleep habits

  At the beginning, mid-term and completion of the study

• Anxiety self-perception

  At the beginning, mid-term and completion of the study

Study Arms (1)

Stress study participants

Adults who reported stress problems derived from work

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

Interventions

Xiaomi MiBand3 DEVICE

Recording of sleep, activity and heart rate data to study their association with stress.

Stress study participants

Socio-demographic questionnaire OTHER

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

Stress study participants

EuroQol-5D-5L OTHER

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.

Stress study participants

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.

Stress study participants

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.

Stress study participants

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 study participants

Stress questionnaire OTHER

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.

Stress study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Working population in a research center, who accept and consent to participate in a stress project.

You may qualify if:

• To be developing their professional activity in a research center

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Center on Information and Communication Technologies: collaborator
• Universidade do Porto: collaborator

Study Sites (1)

Universidade da Coruña

A Coruña, 15006, Spain

Location

Related Publications (19)

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  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Traumatic; Burnout, Professional; Sleep Wake Disorders; Anxiety Disorders; Burnout, Psychological

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Occupational Stress; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Pereira, PhD

  Universidade da Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

ES (1)