跳至主要内容
临床试验/NCT06488547
NCT06488547招募中不适用

Musculoskeletal Disorders and Stress Management, in Employees

University of Thessaly4 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
57
试验地点
4
主要终点
Saliva cortisol

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Saliva cortisol

时间窗: 8 weeks

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.

Heart Rate Variability (HRV)

时间窗: 8 weeks

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.

Musculoskeletal symptoms

时间窗: 8 weeks

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.

次要结局

  • Sort Form Health Survey questionnaire (SF-36)(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleni Zigkiri

PhD (c)

University of Thessaly

研究点 (4)

Loading locations...

相似试验

Stress and Musculoskeletal Health in Employees | 临床试验