Stress and Musculoskeletal Health in Employees

NCT06488547 | Recruiting

• 1 other identifier: 2224/14-04-2022
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• Heart Rate Variability (HRV)

  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

  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

  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 Outcomes (1)

• Sort Form Health Survey questionnaire (SF-36)

  8 weeks

Other Outcomes (3)

• Phychosocial work-related stress

  8 weeks

• Perceived Stress

  8 weeks

• Depression - Anxiety - Stress

  8 weeks

Study Arms (2)

Stress Managemenet Group

EXPERIMENTAL

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); Other: Progressive Muscle Relaxation (PMR)

Control Group-CG

NO INTERVENTION

Participants will receive only information regarding ergonomic practices and tips able to be appilied at the workplace.

Interventions

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.

Stress Managemenet Group

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.

Stress Managemenet Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Thessaly: lead
• THE ENDOCRINE UNIT OF THE UNIVERSITY OF ATHENS: collaborator

Study Sites (2)

University of Thessaly

Larissa, Biopolis- Larissa, 41500, Greece

RECRUITING

The Endocrine Unit of the University of Athens

Athens, 11528, Greece

RECRUITING

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Musculoskeletal Diseases; Musculoskeletal Pain; Occupational Stress; Medically Unexplained Symptoms

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eleni Zigkiri, PhD (c)

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni Zigkiri, PhD (c)

CONTACT

+30 6878180765; ezigkiri@uth.gr

Markos Sgantzos, Professor

CONTACT

+30 6944412554; sgantzos@med.uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (c)

Model Details: interventional group and control group

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 5, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-06

Locations

GR (2)