Clinical trial NCT06488547: Stress and Musculoskeletal Health in Employees
Official title: Musculoskeletal Disorders and Stress Management, in Employees
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Diseases or Conditions
Musculoskeletal Pain
Musculoskeletal Health
Stress
Work Related Stress
Occupation-related Stress Disorder
Medically Unexplained Symptoms
Keywords: stress management
stress biomarkers
musculoskeletal health
work-related
biofeedback
saliva cortisol
HRV
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: THE ENDOCRINE UNIT OF THE UNIVERSITY OF ATHENS
First posted: 2024-07-05
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional group and control group
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: 8 weeks
measure: Saliva cortisol
timeFrame: 8 weeks
measure: Musculoskeletal symptoms
timeFrame: 8 weeks
Secondary outcomes:
measure: Sort Form Health Survey questionnaire (SF-36)
timeFrame: 8 weeks
Other outcomes:
measure: Phychosocial work-related stress
timeFrame: 8 weeks
measure: Perceived Stress
timeFrame: 8 weeks
measure: Depression - Anxiety - Stress
timeFrame: 8 weeks
Locations:
city: Larisa
country: Greece
facility: University of Thessaly
state: Biopolis- Larissa
city: Athens
country: Greece
facility: The Endocrine Unit of the University of Athens
Study officials:
affiliation: University of Thessaly
name: Eleni Zigkiri, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakao M. Work-related stress and psychosomatic medicine. Biopsychosoc Med. 2010 May 26;4(1):4. doi: 10.1186/1751-0759-4-4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.