| CTRI Number |
CTRI/2024/09/073551 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Validity and Reliability Study |
| Study Design |
Other |
|
Public Title of Study
|
To develop and establish the low back pain questionnaire among nursing staff |
|
Scientific Title of Study
|
Development, validation AND reliability of work-related low back pain questionnaire
for nursing professionals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranshul |
| Designation |
BPT Student |
| Affiliation |
Maharishi Markandeshwar Medical College |
| Address |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219593561 |
| Fax |
|
| Email |
prapra465@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arushi Mishra |
| Designation |
Assistance Professor |
| Affiliation |
Maharishi Markandeshwar Medical College |
| Address |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti
Maharishi Markandeshwar Medical College and Hospital Kumarhatti
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarita Khadayat |
| Designation |
Assistance Professor |
| Affiliation |
Maharishi Markandeshwar Medical College |
| Address |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti
Maharishi Markandeshwar Medical College and Hospital Kumarhatti
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8979997426 |
| Fax |
|
| Email |
khytsarita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy department room number 510 maharishi markandeshwar university kumarhatti solan |
|
|
Primary Sponsor
|
| Name |
Pranshul |
| Address |
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti Solan |
| 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 |
| Pranshul |
Maharishi Markandeshwar medical college and hospital |
Physiotherapy department room number 510
Solan
HIMACHAL PRADESH |
8219593561
prapra465@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM Medical College Kumarhatti Solan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Nursing staff must be currently employed in hospital
2 Age between 25-35
3 A minimum work experience of 3 year
4 Nurses who are exposure to work related activities that could cause low back pain
5 Complaint of low back pain |
|
| ExclusionCriteria |
| Details |
1 Other health care worker
2 Exclude subject whose low back pain is not work-related and resulting from accident trauma or other
3 Subject diagnose with any spinal disorder recent surgeries or any other severe musculoskeletal disorder
4 Uncooperative patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Work-Related Low Back Pain questionnaire for Nursing Staff |
At baseline and after 72hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
27/09/2024 |
| 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="0"
Months="6"
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
|
The study is divided into 3 Phases Phase 1: Questionnaire design Phase 2: Validation testing Phase 3: Reliability testing Phase 1: In this phase we will conduct face to face interview with nursing staff with more than 5 years of experience in hospital. This phase of the study uses to generate items use literature search to develop the work-related low back pain questionnaire. After developing the question, we will take opinion and suggestion by 5 nursing staff experts. After changes and opinion given by the group of experts on work-related low back pain questionnaire for nursing professional will be established. Phase 2: In this phase we will do content validation of questionnaire for work-related low back pain for nursing staff. We will validate questionnaire by sending questionnaire by E-mail or WhatsApp to the group of 30 experts (academic) with 3 year of experience using 4-point of ordinary scale both quality and content were evaluated. The scale run from 1-4 points with 1=Highly relevant, 2=Quite relevant, 3=Somewhat relevant, 4=Not relevant. After receiving 80% of suggestion in the questionnaire by 30 MSc experts our work-related low back pain questionnaire will be validated Phase 3: The reliability of the tool will be evaluated by using Inter-rater and Test re-test on 250 nursing staff will be evaluated and after 3 days the same nursing staff will be re-evaluated. The Test re-test reliability of questionnaire was evaluated by 2 experts separately. |