| CTRI Number |
CTRI/2025/06/089373 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Questionnaire To Understand How School Children Feel And Experience Pain |
|
Scientific Title of Study
|
Development And Validation Of A Questionnaire On Perception Of Pain Among School Going Children |
| 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 Sneha Mhetre |
| Designation |
Assistant Professor |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY, BELAGAVI |
| Address |
Advance Physiotherapy Centre, OPD No. 39, Sagar Floor,KLE Dr. Prabhakar Kore Hospital
Belgaum
KARNATAKA
590010
India |
| Phone |
9145024691 |
| Fax |
|
| Email |
snehamhetre@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Akanksha Katti |
| Designation |
Intern |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advance Physiotherapy Centre, OPD No. 39, Sagar Floor,KLE Dr. Prabhakar Kore Hospital
Belgaum
KARNATAKA
590010
India |
| Phone |
9742751664 |
| Fax |
|
| Email |
akankshakatti242@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Mhetre |
| Designation |
Assistant Professor |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advance Physiotherapy Centre, OPD No. 39, Sagar Floor,KLE Dr. Prabhakar Kore Hospital
Belgaum
KARNATAKA
590010
India |
| Phone |
9145024691 |
| Fax |
|
| Email |
snehamhetre@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Institute Of Physiotherapy
KLE Campus , Nehru Nagar , Belagavi |
|
|
Primary Sponsor
|
| Name |
KLE Academy Of Higher Education And Research |
| Address |
Advance Physiotherapy Centre OPD No 39,Sagar Floor, KLE DR.Prabhakar Kore Hospital HOSPITAL,BELAGAVI-590010 |
| Type of Sponsor |
Private medical college |
|
|
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 Sneha Mhetre |
KLE DR.Prabhakar Kore Hospital |
Advance Physiotherapy Centre opd no. 39,Sagar Floor, Kle Dr. Prabhkar Kore Hospital
Belgaum
KARNATAKA |
9145024691
snehamhetre@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH & ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PERCEPTION OF PAIN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Participants must be 10 to 16 years old at the time of data collection.
The child must be enrolled in a school (government or private) within Belagavi to ensure accessibility and standardized exposure to information.
Ability to understand and respond to questions in the language of the questionnaire.
Willingness to participate in the study (with informed assent from the child and written consent from the parent/guardian).
|
|
| ExclusionCriteria |
| Details |
Children with known cognitive impairments, developmental disorders, or communication disabilities that may affect understanding or response.
Children with chronic illnesses or long-term medical conditions where pain perception might differ significantly (e.g., cancer, juvenile arthritis).
Unwillingness or lack of consent/assent to participate in the study.
Children absent from school during data collection period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Children’s Pain Perception Questionnaire |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/07/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [snehamhetre@klekipt.edu.in].
- For how long will this data be available start date provided 16-06-2025 and end date provided 24-07-2025?
Response (Others) - Life time
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study focuses on the creation and validation of a culturally appropriate and age-specific tool to assess pain perception in school-going children aged 10 to 16 years in Belagavi city. Recognizing the unique ways children experience and express pain, the research aims to fill the gap in reliable, child-friendly assessment methods. The study involves scale development through literature review, expert input, and pilot testing, followed by statistical validation to ensure reliability and validity. The outcome is expected to support healthcare professionals, especially pediatric physiotherapists and clinicians, in better understanding and managing pediatric pain. |