An interventional study of Diaphragmatic breathing (DF) and Progressive Muscle Relaxation (PMR) in Musculoskeletal Diseases or Conditions, Musculoskeletal Pain and Musculoskeletal Health, sponsored by University of Thessaly. Recruiting at 2 sites in Greece. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by University of Thessaly · Not applicable, Interventional, and Prevention
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.
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.
515 studies on the registry are indexed under Musculoskeletal Pain; 127 are open to participants now.
This study's planned enrollment of 57 is below the median of 70 across 370 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →University of Thessaly is the lead sponsor of 195 studies on the registry; 44 are open to participants now.
Compared within Musculoskeletal Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Musculoskeletal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Participants will receive only information regarding ergonomic practices and tips able to be appilied at the workplace.
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) 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Sort Form Health Survey questionnaire (SF-36)
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.
Time frame: 8 weeks
Phychosocial work-related stress
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.
Time frame: 8 weeks
Perceived Stress
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.
Time frame: 8 weeks
Depression - Anxiety - Stress
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.
Time frame: 8 weeks
Started Jun 2024 (actual). Primary completion is estimated for Dec 2026, 30 months after the start.
Of 224 non-industry interventional studies with no phase under Musculoskeletal Pain, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's planned 30 months is above that.
Counting every sponsor, half of 237 studies reached it within 13 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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