| CTRI Number |
CTRI/2025/08/093405 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Translation and Validation of Hindi Version of the Neuropathic Pain Scale |
|
Scientific Title of Study
|
Translation, Adaptation, and Validation of Hindi Version of the Neuropathic Pain Scale in Patients with Chronic Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Babita Ghai |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009533 |
| Fax |
01722744401 |
| Email |
ghaibabita1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Babita Ghai |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh
CHANDIGARH
160012
India
CHANDIGARH
160012
India |
| Phone |
7087009533 |
| Fax |
01722744401 |
| Email |
ghaibabita1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Babita Ghai |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh
CHANDIGARH
160012
India
CHANDIGARH
160012
India |
| Phone |
7087009533 |
| Fax |
01722744401 |
| Email |
ghaibabita1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh, India-160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pro Babita Ghai |
PGIMER, CHANDIGARH |
Room number 5023, 5th floor, Pain clinic, Department of Anaesthesia and Intensive Care
Chandigarh
CHANDIGARH |
7087009533
ghaibabita1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18 years and above, irrespective of gender. Patients suffering from chronic pain. Patents who are able to speak and understand the Hindi language. Patients willing to provide informed consent form. Patients who were willing to read, understand, and respond to the Hindi version of questionnaires used for the study
|
|
| ExclusionCriteria |
| Details |
Patients with Major depression and history of alcohol Abuse. Patients who will be in the analgesic state, not able to answer the scale item. Pregnant and breast-feeding women will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate cross-cultural validation and psychometric properties of Hindi NPS |
At baseline and at 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Internal consistency , Test-retest reliability, Discriminative validity, Convergent validity Hindi NPS (Hi-NPS) |
baseline and 3 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2025 |
| 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="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
|
| The language barrier is an important concern in the native language population limiting the application of any questionnaires beyond the population where the score was created and developed. To guarantee the precision of any patient-reported outcome measures (PROM) across diverse cultures, there should be a linguistic and cultural adaptation for a definite population in obedience to guidelines for cross-cultural validation of PROM . Hindi is the most extensively used dialect in India, second most populous country in the World. To the best of our knowledge, NPS has not been translated into Hindi and the psychometric properties (validity, reliability, and responsiveness) of the Hindi Version of NPS have not been done to date.
|
Aim of the current study is to translate the Neuropathic Pain Scale in Hindi language and cross-culturally validate the Hindi version of The Neuropathic Scale (Hi-NPS).
The present study will be a cross-sectional survey with a sample size of 50.
Assessment tools: 1. The Neuropathic Pain Scale (NPS)
2. EuroQOL 5D-5L |