| CTRI Number |
CTRI/2024/03/064548 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translate and validate NIOSH worker well being questionnaire in hindi and marathi |
|
Scientific Title of Study
|
Cross Cultural Adaptation and Validation of Hindi and Marathi version of the NIOSH Worker Well-Being Questionnaire |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithin Ravindran Nair PT |
| Designation |
Assistant Professor |
| Affiliation |
MGM COLLEGE OF PHYSIOTHERAPY |
| Address |
MGM College of Physiotherapy, Department of Community Physiotherapy, Sector 30, Vashi, Navi Mumbai - 400705
Thane
MAHARASHTRA
400705
India |
| Phone |
9167292084 |
| Fax |
|
| Email |
nithinn11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithin Ravindran Nair PT |
| Designation |
Assistant Professor |
| Affiliation |
MGM COLLEGE OF PHYSIOTHERAPY |
| Address |
MGM College of Physiotherapy, Department of Community Physiotherapy, Sector 30, Vashi, Navi Mumbai - 400705
Thane
MAHARASHTRA
400705
India |
| Phone |
9167292084 |
| Fax |
|
| Email |
nithinn11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithin Ravindran Nair PT |
| Designation |
Assistant Professor |
| Affiliation |
MGM COLLEGE OF PHYSIOTHERAPY |
| Address |
MGM College of Physiotherapy, Department of Community Physiotherapy, Sector 30, Vashi, Navi Mumbai - 400705
Thane
MAHARASHTRA
400705
India |
| Phone |
9167292084 |
| Fax |
|
| Email |
nithinn11@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM College of Physiotherapy, Department of Community Physiotherapy, Sector 30, Vashi, Navi Mumbai - 400705 |
|
|
Primary Sponsor
|
| Name |
Dr Nithin Ravindran Nair PT |
| Address |
MGM College of Physiotherapy |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nithin Ravindran Nair |
MGM HOSPITAL |
MGM College of Physiotherapy, Department of Community Physiotherapy, Sector 30, Vashi, Navi Mumbai - 400705
Thane
MAHARASHTRA |
9167292084
nithinn11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MGMDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
1.Health care workers such as physicians, nursing and midwifery professionals, paramedical/allied health practitioners, technical personnel etc. of the age group 25 to 58 years
2.Participants having more than 1 year of work experience.
3.Participants who are willing to participate in this study
|
|
| ExclusionCriteria |
| Details |
1.Participants who are not willing to participate in this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hindi & Marathi version - NIOSH WellBQ |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/04/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TRANSLATION OF THE NIOSH WORKER WELL BEING QUESTIONNAIRE Forward Translation, Synthesis of translated version, Back Translation, Synthesis of translated version, Expert Committee: PRE-TESTING OF THE NIOSH WORKER WELL BEING QUESTIONNAIRE The final Hindi and Marathi versions of the questionnaire will then be field-tested among 30-40 respondents each as viewed appropriate. Based on the results of the pilot study, the research team will make final semantic adjustment. The translated questionnaire will then be administered to the target population. The psychometric properties of the instrument will be evaluated using appropriate statistical techniques in light of the study’s findings. MAIN STUDY The cross-sectional study will be conducted after obtaining approval from IERC. Participants (Healthcare Workers) will be recruited from tertiary care hospitals on the basis of inclusion and exclusion criteria and a written informed consent will be taken from them. Before initiating the study following demographic characteristics of the participants will be collected – age, gender, education, working site, years of experience, number of working days in a week, total working hours per day, addictions, co-morbidities etc. After that, each participant will be given enough time and privacy to complete the self-reported translated version of NIOSH Worker Well Being questionnaire. |