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CTRI Number  CTRI/2023/03/050232 [Registered on: 02/03/2023] Trial Registered Prospectively
Last Modified On: 01/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   A clinical trial to study the effects of stretching exercises on work-related musculoskeletal symptoms. 
Scientific Title of Study   : “A study to evaluate the effectiveness of stretching exercises on work-related musculoskeletal symptoms among security guards of MAHE Manipal.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Loretta Veena Dsilva 
Designation  Final year M.Sc. Nursing student 
Affiliation  Manipal College of Nursing Manipal 
Address  Medical -Surgical Nursing department Manipal College of Nursing MAHE Manipal
Medical - Surgical Nursing department Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  9008419866  
Fax    
Email  lorettaveena@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Elsa Sanatombi Devi 
Designation  Professor 
Affiliation  Manipal College of Nursing Manipal 
Address  Medical - Surgical Nursing department Manipal College of Nursing MAHE Manipal
Medical- Surgical Nursing department Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  8310769938  
Fax    
Email  elsa.sana@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sushmita R Karkada 
Designation  Assistant Professor - Senior Scale 
Affiliation  Manipal College of Nursing Manipal 
Address  Obstetrics and Gynaecology Nursing department Manipal College of Nursing MAHE Manipal
Obstetrics and Gynaecology Nursing department Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  9964144224  
Fax    
Email  sushmitha.karkada@manipal.edu  
 
Source of Monetary or Material Support  
Study is conducted in Manipal Academy of Higher Education (MAHE)Manipal campus 
 
Primary Sponsor  
Name  Loretta Veena Dsilva 
Address  Manipal College of Nursing MAHE Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Elsa Sanatombi Devi  Manipal Academy of Higher Education Manipal basic health science and kasturba hospital campus (MAHE)  Manipal
Udupi
KARNATAKA 		 8310769938

elsa.sana@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Demonstrating stretching exercises to reduce or minimize the work-related musculoskeletal symptoms 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Stretching exercise  It includes six types of stretching exercises like Trapezius Stretch, Shoulder stretch, Forearm stretch, Trunk rotation, Hamstring stretch, and Calf stretch. These exercises will be thought for 1month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  Phase 1
Inclusion criteria:
Security guards:
• All security guards employed at MAHE Manipal, are between 18 to 58 years old.
• Security guards who are willing to participate in the study
Phase 2
Inclusion criteria:
• Security guards who have work-related musculoskeletal symptoms.
• Security guards who are willing to participate in the study 
 
ExclusionCriteria 
Details  Phase 1
Exclusion criteria:
•Security guard who underwent surgery in the past, comorbidities like heart-related problems,
and fractures that prevent him/her from doing stretching exercises.
Phase 2
Exclusion criteria:
• Security guards who do not have work-related musculoskeletal symptoms.
• Security guards who have a recent history of surgeries, accidents, or disabilities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to reduce or minimize work-related musculoskeletal symptoms  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Demonstrating the stretching exercises to reduce or minimize the work- related musculoskeletal symptoms  after 1 month follow up 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title
"A study to evaluate the effectiveness of stretching exercises on work-related musculoskeletal symptoms among security guards of MAHE Manipal". 
Purpose of the study 
This study is to investigate the health problems of security guards with a particular focus on work-related musculoskeletal symptoms related to physical aspects of the work (muscular pain due to bad postures, repetitive movements, prolonged stretching of muscles, exertion, etc. leading to painful discomfort in caring out regular work) based on their self-reported outcomes. This study aims to determine how regular stretching exercises reduce or minimize work-related musculoskeletal symptoms among security guards. 
Objectives 
The objectives of the study are to: 
 â€¢Identify the work-related musculoskeletal symptoms among all security guards as measured by a standardized Nordic questionnaire. 
• Assess the pain level of those with work-related musculoskeletal symptoms using a Numerical rating scale. 
• Evaluate the effectiveness of stretching exercises’ in reducing work-related musculoskeletal symptoms as measured by a Numerical rating scale. 
Hypotheses 
 The hypotheses will be tested at a 0.05 level of significance. 
 H1: There will be a significant difference in the pre-and post-test level of work-related musculoskeletal symptoms among security guards after the intervention.
 
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