Stress and Musculoskeletal Health in Employees (MUStress)

June 27, 2024 updated by: Eleni Zigkiri, University of Thessaly

Musculoskeletal Disorders and Stress Management, in Employees

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Eleni Zigkiri, PhD (c)
  • Phone Number: +30 6878180765
  • Email: ezigkiri@uth.gr

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • The Endocrine Unit of the University of Athens
        • Contact:
    • Biopolis- Larissa
      • Larisa, Biopolis- Larissa, Greece, 41500
        • Recruiting
        • University of Thessaly
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eleni Zigkiri, PhD (c)

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress Managemenet Group

Participants will be instructed and trained with two stress management techniques (Diaphragmatic Breathing- DB and Progressive Muscle Relaxation-PMR), along with biofeedback training in diaphragmatic breathing.

During the eight weeks of the program, participants in the intervention group will receive information regarding stress, work-related stress factors, musculoskeletal health and disorders, the Medically Unexplained Symptoms-MUS, occupational psychosocial hazards, lifestyle habits (healthy diet, sedentary life, sleep, hygiene).

Moreover, participants will be informed about how to manage stress related factors at the workplace, and its symptoms, through lifestyle modifications along with ergonomic guidance at work and in relation with their musculoskeletal health, the psychosocial hazards at work and their body response to work-related stress.
Other: Diaphragmatic breathing (DF)
Diaphragmatic breathing (DF), also known as belly or abdominal breathing, is a technique that can teach people how to use their diaphragm correctly while breathing, in order to activate the parasympathetic branch of the autonomic nervous system and to control stress.
Other: Progressive Muscle Relaxation (PMR)

Progressive Muscle Relaxation (PMR) is a technique that is helpful in the reduction of stress.

PMR by alternately tensing and relaxing different muscle groups in the body helps participants to become more aware of physical sensations and can be particularly helpful to muscle tension and relaxation.
No Intervention: Control Group-CG
Participants will receive only information regarding ergonomic practices and tips able to be appilied at the workplace.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sort Form Health Survey questionnaire (SF-36)
Time Frame: 8 weeks

Quality of life will be measured with the Short Form survey (SF-36) self-report questionnaire. SF-36 provides comprehensive information of an individual health status and assesses eight domains of health such as: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/ fatigue (vitality), Emotional wellbeing, Social functioning, Pain, and General health. It provides valuable insights into participants' perceived health status and overall quality of life. All questions are scored on a scale from 0 to 100, reflecting a range from lowest to highest possible quality of life.

Scoring the SF-36 involves a two-step process. At first each question must be pre- coded with a numeric value which is then recorded according to a scoring key and then the second step involves averaging the recorded values from items within the same scale to compute the total scale score.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phychosocial work-related stress
Time Frame: 8 weeks
Psychosocial work-related stress factors will be measured with the Copenhagen Psychosocial Questionnaire (COPSOQ-II medium version). The medium version of the questionnaire consists of 8 domains, 28 dimensions and 87 items. Each item scores from 0-100 (i.e. 0, 25, 50, 75, and 100 for a five response category item). The scale score is computed as the mean item score. Higher total score indicates that the employee experiences greater work-related psychosocial risk factors.
8 weeks
Perceived Stress
Time Frame: 8 weeks
Perceived stress will be measured with the Perceived Stress Scale (PSS-14), which is a self-report questionnaire with 14 items. It measures the perception of stressful experiences of the responder by rating the frequency of the feelings and thoughts related to events over the past month. Between items half of them are considered negative and the other as positive. Each answer responds on a five point Likert-type scale (0-never to 4=very often). Total score ranges from 0-56 and higher scores indicate greater perceived stress.
8 weeks
Depression - Anxiety - Stress
Time Frame: 8 weeks
Depression, Anxiety and Stress parameters will be measured with the Depression Anxiety Stress Scales (DASS-21), which is a self-reported questionnaire designed to measure the emotional states of depression, anxiety and stress. It consists of three subscales of depression, anxiety and stress. Each subscale consists of seven items which are answered on a 4-point Likert-type scale. the answers ranging from 0 ("does not apply to me at all") to 3 ("applies to me very much") scales. The score of each subscale has to be multiplied by 2 to obtain the total subscale scores. The total scores of each subscale range from 0 to 42 points, with higher scores indicating more severe depression/anxiety/stress symptoms.
8 weeks

Collaborators and Investigators

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

Sponsor

University of Thessaly

Collaborators

THE ENDOCRINE UNIT OF THE UNIVERSITY OF ATHENS

Investigators

  • Principal Investigator: Eleni Zigkiri, PhD (c), University of Thessaly

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)

June 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2224/14-04-2022

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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