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CTRI Number  CTRI/2021/04/033082 [Registered on: 26/04/2021] Trial Registered Prospectively
Last Modified On: 23/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   assessing the musculoskeletal disorders (MSDs) and the contributing factors among nursing students 
Scientific Title of Study   A study to assess the musculoskeletal disorders (MSDs) and the contributing factors among student nurses in a selected college of Udupi district, Karnataka, India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lola Naresh 
Designation  M Sc Nursing student 
Affiliation  Manipal college of nursing 
Address  Room no 402 Department of Medical Surgical Nursing Manipal Manipal College of Nursing Manipal Manipal Academy of Higher Education Manipal
Room no 402 Department of Medical Surgical Nursing Manipal Manipal College of Nursing Manipal Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India 
Phone  7569493074  
Fax    
Email  lolanaresh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Leena Sequira 
Designation  Principal 
Affiliation  Manipal School of Nursing 
Address  Room No 504 Manipal School of Nursing Manipal Manipal Academy of Higher Education Manipal
Room No 504 Manipal School of Nursing Manipal Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India 
Phone  9481971214  
Fax    
Email  leena.sequ@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Lola Naresh 
Designation  M Sc Nursing student 
Affiliation  Manipal college of nursing 
Address  Room no 402 Department of Medical Surgical Nursing Manipal Manipal College of Nursing Manipal Manipal Academy of Higher Education Manipal
Room no 402 Department of Medical Surgical Nursing Manipal Manipal College of Nursing Manipal Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India 
Phone  7569493074  
Fax    
Email  lolanaresh@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Lola Naresh 
Address  Manipal College of Nursing Manipal Manipal Academy of Higher Education Manipal 
Type of Sponsor  Other [Self funded] 
 
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 Anice George  Manipal College of Nursing  Room No 101 Manipal College of Nursing Manipal Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA 
9632094766

anice.george@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Nursing students who are available during data collection
Nursing students who are willing to participate in the study 
 
ExclusionCriteria 
Details  Nursing students who are having Musculoskeletal disorders before joining the nursing course 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the musculoskeletal disorders among student nurses  10-12-2020 to 17-11-2021 
 
Secondary Outcome  
Outcome  TimePoints 
Identify the contributing factors of musculoskeletal disorders among student nurses  10-12-2020 to 17-11-2021 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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)   26/04/2021 
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 Applicable 
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   after obtaining permission from the concerned authorities and IEC approval CTRI registration, the samples will be obtained through a convenient sampling technique. Online survey forms will be created and links will be sent through email ids along with informed consent from the study participants 
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