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Trial details
Ergonomics and Mindfulness for preventing musculoskeletal pain and a better quality of life
Current status:
Approved
|
Date registered:
18/10/2022
Trial version(s)
Current: 19/09/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022095130
Protocol number
CEHDF2040
MOH registration number
CEHDF 2040
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
19/09/2022
Primary sponsor
Dr Sandra Kobaiter Maarrawi
Primary sponsor: Country of origin
Lebanon
Public title
Ergonomics and Mindfulness for preventing musculoskeletal pain and a better quality of life
Acronym
Scientific title
Effect of ergonomics and mindfulness on musculoskeletal pain and quality of life for office workers: a randomized controlled trial
Acronym
Brief summary of the study: English
With the introduction of computers on a global scale, we find their increasing use, especially in workplaces. Although computer use has improved worker productivity, this change has also led to adverse health impacts including work-related musculoskeletal disorders and consequently a deterioration in the quality of life. Pain is often reported in these disorders and is one of the early signs of their development. Determining its presence in professional life and identifying the factors that cause it is important in order to take the necessary corrective measures and plan preventive actions. Office workers are known to be exposed to major stress and to sit in a static position for a long period of time, which make them at risk of developing potentially chronic pain and quality of life deterioration. This could be prevented by implementing interventions that target the multiple aspects of pain (physical and mental) and improve quality of life. Ergonomic interventions are proven to be effective in fixing bad posture by adapting the office environment, which has a positive impact on musculoskeletal pain. Moreover, Mindfulness interventions are a growing interest since its emergence in 1990. By establishing a new way of thinking, consciousness without judgment of the present experience, it has been proven to reduce stress and improve well-being. The aim of this study is to evaluate the effect of multifactorial interventions (ergonomics and mindfulness) in reducing pain and improving quality of life in office workers.
Brief summary of the study: Arabic
في ظل الإنتشار العالمي لأجهزة الكمبيوتر، نجد تزايد في إستخدامها وبصورة خاصة في أماكن العمل. من المؤكد انّ استخدام الكمبيوتر أدى إلى تحسين إنتاجية العمال ولكن لا بد من الإشارة أن هذا التغيير ينتج أضرار صحية منها الاضطرابات العضلية الهيكلية المرتبطة بالعمل وبالتالي تدهور جودة الحياة. غالبًا الألم في هذه الاضطرابات يعتبر اشارة مبكرة لتطورها، لذلك من المهم تحديد وجودها في الحياة المهنية وتحديد العوامل المسببة لها من أجل اتخاذ الإجراءات الصحيّة والوقائية. إن العاملين في المكاتب معرضين لضغط كبير ولفترة جلوس طويلة، ما يزيد من خطر إصابتهم بآلام مزمنة وما يؤثر سلبًا على مستوى حياتهم. من الممكن منع هذه الأضرار من خلال تنفيذ تدخلات جسديّة وعقليّة لأماكن الألم . فقد أثبتت التدخلات المريحة فعاليتها في إصلاح المشاكل من خلال تكييف بيئة المكتب، ما يخفف من آلام العضلات والعظام. كما يمكننا القول ان تدخلات اليقظة اثبتت اهتمامًا متزايدًا منذ ظهورها في عام ١٩٩٠، من خلال إنشاء طريقة جديدة في التفكير. فقد ثبّت أنها تقلل التوتر وتعزز الرفاهية. فالهدف من هذه الدراسة هو تقييم تأثير التدخلات متعددة العوامل (بيئة العمل واليقظة) في تقليل الألم وتحسين نوعية الحياة للعاملين في مكاتبهم.
Health conditions/problem studied: Specify
Musculoskeletal pain - prevention well being of office workers
Interventions: Specify
Name : Ergonomics - Description : workstation adjustments based on anthropometric measures, and follow-up visits, once a week for a duration of 5 weeks. Name : Mindfulness - Description : new mindfulness-based program, administrated as group sessions once a week for a duration of 5 weeks. Control : placebo
Key inclusion and exclusion criteria: Inclusion criteria
- Office workers aged between 18 and 64-year-old (legal work age in Lebanon) - Female (because pain perception defers based on sex) - Experiencing non-specific pain related to work - Work for at least 20h / week
Key inclusion and exclusion criteria: Gender
Female
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
64
Key inclusion and exclusion criteria: Exclusion criteria
- Obesity (IMC > 30 Kg/m2) - Not having a fixed workstation, sharing a workstation with a co-worker, using a laptop computer, using two monitors - Having undergone surgery in the previous six months - Pain due to a medical condition, pregnancy or menstruation - Taking pain medication on a regular basic
Type of Study
Type
Interventional
Type of intervention
Preventive measures
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
N/A
Study design: Purpose
Prevention
Study design: Assignment
Parallel
Pharmaceutical class
NA
Therapeutic indication
prevention of musculoskeletal pain
Therapeutic benefit
better well being, alleviate and prevent musculoskeletal pain
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
80
Actual enrollment target size
30
Date of first enrollment: Type
Actual
Date of first enrollment: Date
03/10/2022
Date of study closure: Type
Actual
Date of study closure: Date
19/12/2023
Recruitment status
Recruiting
Date of completion
03/07/2023
IPD sharing statement plan
No
IPD sharing statement description
NA
Additional data URL
NA
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Saint Joseph University of Beirut (USJ)
LAREN_22-23_Ergo
Sources of Monetary or Material Support
Name
Saint Joseph University of Beirut (USJ)
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Dr Sandra
Kobaiter Maarrawi
USJ - Faculty of Medicine - Laboratory of Research in Neuroscience
Lebanon
009611421677
sandra.kobaitermaarrawi@usj.edu.lb
Saint Joseph University of Beirut
Scientific
Nay
El Hajj
USJ - Faculty of Medicine - Laboratory of Research in Neuroscience
Lebanon
0096171706646
nay.hajj@net.usj.edu.lb
Saint Joseph University of Beirut
Scientific
Dr Sandra
Kobaiter Maarrawi
USJ - Faculty of Medicine - Laboratory of Research in Neuroscience
Lebanon
0096171207772
s_kobaiter@hotmail.com
Saint Joseph University of Beirut
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Laboratory of Research in Neuroscience
Dr Sandra Kobaiter Maarrawi
Neuroscience
Approved
Institute of Occupational Therapy (ergonomics)
Dr Carla Matta Abi Zeid
Psychomotricity
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
25/07/2022
Pr Michel Scheuer sj
cue@usj.edu.lb
009611421229
Countries of Recruitment
Name
Lebanon
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Musculoskeletal pain
Pain, not elsewhere classified (R52)
pain
well being
2-Propanol (T51.2)
quality of life
Interventions
Intervention
Description
Keyword
Mindfulness
new mindfulness- occupational based program, inspired from conventional MBCT and MBSR, administrated as group sessions once a week for a duration of 5 weeks.
Mindfulness
Ergonomics
workstation adjustments based on anthropometric measures, and follow-up visits, once a week for a duration of 5 weeks.
ergonomic
Primary Outcomes
Name
Time points
Measure
Pain
at baseline, During the 2 weeks following end of treatment, and after 6 months
Visual analog scale
Quality of Life
at baseline, During the 2 weeks following end of treatment, and after 6 months
The 12-Item Short Form Health Survey (SF-12)
Key Secondary Outcomes
Name
Time points
Measure
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial