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Clinical Trials/NCT06488547
NCT06488547
Recruiting
Not Applicable

Musculoskeletal Disorders and Stress Management, in Employees

University of Thessaly2 sites in 1 country57 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal Diseases or Conditions
Sponsor
University of Thessaly
Enrollment
57
Locations
2
Primary Endpoint
Saliva cortisol
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to evaluate potential correlation of stress as estimated by certain biological markers, namely saliva cortisol, Heart rate variability (HRV), Electromyography (EMG) with musculoskeletal system health status, and assess the impact of a stress management intervention..The intervention group will be trained to apply two evidence based stress management techniques and they will be guided with tips and advice about musculoskeletal health.

Impact of the intervention upon measured stress related markers will be assessed.

Detailed Description

The goal of this non-pharmacological randomized interventional study is to investigate work-related stress in relation to the musculoskeletal health of employees. The primary purpose of this study is to investigate if stress management interventions in employees can improve self-reported musculoskeletal health problems or Medically Unexplained Symptoms (MUS), in relation with biomarkers of stress. Secondary outcomes will include quality of life improvement and the number of absences from work, due to musculoskeletal conditions. The main question aims to answer if specific stress management techniques can improve the self-reported musculoskeletal health of employees. Researchers will compare the results between two groups (one participating in the the six (6) week program and the other not participating) to measure the effect size in the intervention group and between groups. Participants from both groups will be measured twice (on week 1 and week 8) with the same self-report questionnaires and stress biomarkers, if possible. Especially for the intervention group a six-week stress management program will be applied. This will include the participation in one and a half hour consultation meetings about stress, musculoskeletal health, psychosocial work-related factors, and how to improve well-being and work/life satisfaction.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eleni Zigkiri

PhD (c)

University of Thessaly

Eligibility Criteria

Inclusion Criteria

  • Writing and reading greek.
  • Consent to provide their medical history.
  • Consent to be measured with electronic devices.

Exclusion Criteria

  • Employees who are close to retirement (at least 2 years before) and those for whom any known factor may prevent them from completing the intervention (eg travel, transfer).
  • Pregnancy.
  • Pacemaker, history of seizures.
  • Diagnosed musculoskeletal injury.
  • Diagnosed diseases such as: osteoarthritis, autoimmune diseases (rheumatoid arthritis, lupus, etc.), stroke, myocardial infarction, malignant neoplasms, psychiatric disease, disability.
  • Systematic reception of cortisone and anti-inflammatory treatment, up to at least three months before the intervention.
  • Drugs or substances.
  • Participation in another interventional program of musculoskeletal rehabilitation, physical therapy, stress management or health promotion.

Outcomes

Primary Outcomes

Saliva cortisol

Time Frame: 8 weeks

Salivary cortisol has been used as an indicator for stress. Pre-post intervention differences between diurnal circadian rhythm in the saliva cortisol of the participants will be measured, in order to evaluate the efficiency of the intervention upon homeostatic load.

Heart Rate Variability (HRV)

Time Frame: 8 weeks

Heart Rate Variability (HRV) has been widely used as an indicator for work-related stress. It measures the variation in time between each heartbeat and is controlled by the autonomic nervous system.

Musculoskeletal symptoms

Time Frame: 8 weeks

Musculoskeletal symptoms will be assessed with the Nordic Musculoskeletal Questionnaire (NMQ). NMQ is a standardized questionnaire for the assessment of musculoskeletal problems in nine different body regions (neck, shoulders, upper back, elbows, wrist/hands, lower back, hips/thighs, knees, ankles/feet). General questions include 40 forced-choice items where responders could indicate if they had musculoskeletal problems (aches, pain, discomfort) in the last 12 months or seven days. Additional questions ask the participants to report if the musculoskeletal problems had led to inability to perform daily tasks and normal activities. Work-related stress can lead to physical strain, which in turn can lead to musculoskeletal tension and disorders. Musculoskeletal disorders (MSDs) are a common type of occupational diseases and have become the main cause of absenteeism and early retirement in the working population.

Secondary Outcomes

  • Sort Form Health Survey questionnaire (SF-36)(8 weeks)

Study Sites (2)

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