Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
57 participants
INTERVENTIONAL
2024-06-01
2026-12-31
Brief Summary
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Impact of the intervention upon measured stress related markers will be assessed.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
Control Group-CG
Participants will receive only information regarding ergonomic practices and tips able to be appilied at the workplace.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Consent to provide their medical history.
* Consent to be measured with electronic devices.
Exclusion Criteria
* 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.
19 Years
ALL
Yes
Sponsors
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THE ENDOCRINE UNIT OF THE UNIVERSITY OF ATHENS
UNKNOWN
University of Thessaly
OTHER
Responsible Party
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Eleni Zigkiri
PhD (c)
Principal Investigators
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Eleni Zigkiri, PhD (c)
Role: PRINCIPAL_INVESTIGATOR
University of Thessaly
Locations
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University of Thessaly
Larissa, Biopolis- Larissa, Greece
The Endocrine Unit of the University of Athens
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Nakao M. Work-related stress and psychosomatic medicine. Biopsychosoc Med. 2010 May 26;4(1):4. doi: 10.1186/1751-0759-4-4.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2224/14-04-2022
Identifier Type: -
Identifier Source: org_study_id
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