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CTRI Number  CTRI/2021/01/030438 [Registered on: 13/01/2021] Trial Registered Prospectively
Last Modified On: 12/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of musculoskeletal pain with sleeplessness and Body mass index among industry workers in Rajkot- An Observational Study 
Scientific Title of Study   Association of musculoskeletal pain with insomnia and BMI among industry workers in Rajkot- An Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansi Patel 
Designation  Post Graduate student 
Affiliation  School of Physiotherapy, RK UNIVERSITY  
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway

Rajkot
GUJARAT
360002
India 
Phone  9737900234  
Fax    
Email  mpatel067@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Krupa Tank 
Designation  Assistant Professor  
Affiliation  School of Physiotherapy, RK UNIVERSITY  
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway

Rajkot
GUJARAT
360002
India 
Phone  9998810063  
Fax    
Email  krupa.tank@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Mansi Patel 
Designation  Post Graduate student 
Affiliation  School of Physiotherapy, RK UNIVERSITY  
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway

Rajkot
GUJARAT
360002
India 
Phone  9737900234  
Fax    
Email  mpatel067@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiotherapy, RK. UNIVERSITY  
 
Primary Sponsor  
Name  MANSI PATEL 
Address  School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway. 
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 
Mansi Patel  M. Tech Fasteners  G-1142, Lodhika GIDC, Metoda-360021
Rajkot
GUJARAT 		 9737900234

mpatel067@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, School of Physiotherapy, RK University, Rajkot-Bhavnagar Highway Tramba Rajkot-360020 Gujarat India.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Musculoskeletal pain,insomnia,BMI 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Age between 21 to 60 years
More than 1 year experience
Work more than 9 hours/day
Working days 6 days/week
 
 
ExclusionCriteria 
Details  History of trauma & surgery
Who are taking medication of insomnia
subject who are doing night shift 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cornell Musculoskeletal Discomfort Questionnaire  on first day 
 
Secondary Outcome  
Outcome  TimePoints 
Insomnia Severity Index  on first day 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   15/01/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

TOPIC: Association of musculoskeletal pain with insomina and BMI among industry workers in Rajkot – An Observational Study

 

 INVESTIGATOR:  MANSI PATEL School Of Physiotherapy RK University

 

AIM: To determine the association of musculoskeletal pain with insomina and BMI among industry workers in Rajkot.

 

OBJECTIVE:

•      To astimate the association of musculoskeletal pain with insomina among industry workers in Rajkot.

•       To astimate the association of musculoskeletal pain with BMI among industry workers in Rajkot.

 

MATERAIL: google form, pen, paper, calculator, BMI  calculator application, laptop

 

PROCEDURE:

  • After approval from ethical commity study will be started by consent form and explain procedure
  • Subject will be as per inclusion and exclusion criteria
  • Then prepare questionnaire and share through google form
  • Analysis will be done using SPSS software

The questionnaire will divide in 3 parts,

 [1] demographic data (Name, age, gender, mobile number, email          address, name of Industry, height, weight, working hours, working day, sleeping pills)

 [2] Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)

 [3] Insomnia Severity Index (ISI) [ Hindi version ]

 

 


 
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