Stress and Musculoskeletal Health in Employees

Официальное название

Musculoskeletal Disorders and Stress Management, in Employees

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Heart Rate Variability (HRV) [Срок оценки: 8 weeks]
• Saliva cortisol [Срок оценки: 8 weeks]
• Musculoskeletal symptoms [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• Sort Form Health Survey questionnaire (SF-36) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Греция · 2 центра

• University of Thessaly — Larissa
• The Endocrine Unit of the University of Athens — Athens

Публикации

• Nakao M. Work-related stress and psychosomatic medicine. Biopsychosoc Med. 2010 May 26;4(1):4. doi: 10.1186/1751-0759-4-4. PMID 20504368
• Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8. PMID 28478782
• Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014. PMID 25101026
• Eatough EM, Way JD, Chang CH. Understanding the link between psychosocial work stressors and work-related musculoskeletal complaints. Appl Ergon. 2012 May;43(3):554-63. doi: 10.1016/j.apergo.2011.08.009. Epub 2011 Sep 23. PMID 21944295
• Buscemi V, Chang WJ, Liston MB, McAuley JH, Schabrun SM. The Role of Perceived Stress and Life Stressors in the Development of Chronic Musculoskeletal Pain Disorders: A Systematic Review. J Pain. 2019 Oct;20(10):1127-1139. doi: 10.1016/j.jpain.2019.02.008. Epub 2019 Feb 22. PMID 30797962
• Maina G, Palmas A, Bovenzi M, Filon FL. Salivary cortisol and psychosocial hazards at work. Am J Ind Med. 2009 Mar;52(3):251-60. doi: 10.1002/ajim.20659. PMID 19023870
• Wang J, Zhu L, Song L, Zhou Z, Chan W, Li G, Zhou L, Xiao J, Lian Y. A cohort study on the association between changing occupational stress, hair cortisol concentration, and hypertension. PLoS One. 2023 May 17;18(5):e0285623. doi: 10.1371/journal.pone.0285623. eCollection 2023. PMID 37196014

Идентификаторы

NCT: NCT06488547 · 2224/14-04-2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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