| CTRI Number |
CTRI/2025/10/096018 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Nurses Use Ergonomics: A Questionnaire Study” |
|
Scientific Title of Study
|
Development and Validation of a Questionnaire to Assess Nurses Knowledge and Practice of Ergonomics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B K Poorvi |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy,
M S Ramaiah Nagar, MSRIT Post,
Bengaluru, Karnataka- 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9108435634 |
| Fax |
|
| Email |
poorvigowda64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Diana Rodrigues |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy,
M S Ramaiah Nagar, MSRIT Post,
Bengaluru, Karnataka- 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9916247023 |
| Fax |
|
| Email |
diana.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Diana Rodrigues |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy,
M S Ramaiah Nagar, MSRIT Post,
Bengaluru, Karnataka- 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9916247023 |
| Fax |
|
| Email |
diana.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
B K Poorvi |
| Address |
Ramaiah College of Physiotherapy,
M S Ramaiah Nagar, MSRIT Post,
Bengaluru, Karnataka- 560054 |
| 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 |
| B K Poorvi |
Ramaiah Medical College Hospital |
Ramaiah Medical College Hospital
M S Ramaiah Nagar, MSRIT Post,
Bengaluru, Karnataka- 560054
Bangalore
KARNATAKA |
9108435634
poorvigowda64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy registered nurses working in hospital settings. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Nurses with a minimum one-year experience
Nurses working in various clinical settings such as ICU, IPD and OT
Actively engaged in clinical duties involving patient handling or prolonged static and awkward postures
Ability to read and understand the questionnaire in English
Those willing and consenting to participate |
|
| ExclusionCriteria |
| Details |
Nurses who are registered members of the Occupational Safety and Health (OSH) Committee
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development and validation of a questionnaire to assess nurses’ knowledge and practice of ergonomics |
20-30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Test–retest reliability (stability)
2. Knowledge score & Practice score
3. Item analysis / Acceptability
4. Questionnaire feasibility/usability |
8 months questionnaire development
3 months data collection |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
03/11/2025 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study titled Development and Validation of a Questionnaire to Assess Nurses Knowledge and Practice of Ergonomics is a cross-sectional methodological study to be conducted at Ramaiah Hospitals Bengaluru from August 2025 to July 2026 It aims to develop and validate a questionnaire assessing ergonomic knowledge and practices among nurses focusing on domains such as body posture musculoskeletal risk factors safe patient handling workstation ergonomics and rest or recovery strategies Around 100 nurses aged 25 to 60 years with at least one year of clinical experience will be included while OSH committee members will be excluded The tool will be developed through literature review expert consensus like modified Delphi process and refined into approximately 20 items with the knowledge section assessed by MCQs or True or False and the practice section by a 5 point Likert scale Validation will include face content and construct validity via exploratory factor analysis followed by pilot testing for reliability The primary outcome will be a reliable and valid tool to assess ergonomic knowledge and practice with data collection conducted ethically ensuring informed consent confidentiality and voluntary participation |