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NCT Number: NCT06488547

Stress and Musculoskeletal Health 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Thessaly, Larissa, Biopolis- Larissa, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diaphragmatic breathing (DF)

Other

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.

Progressive muscle relaxation (PMR)

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eleni Zigkiri, PhD (c)

CONTACT

[email protected]

+30 6878180765

Markos Sgantzos, Professor

CONTACT

[email protected]

+30 6944412554

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • University of Athens

Registry information

Official study title

Musculoskeletal Disorders and Stress Management, in Employees

Acronym: MUStress

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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