| CTRI Number |
CTRI/2026/01/101313 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand how well children recover after orthopedic surgery using a simple questionnaire adapted in the Hindi language |
|
Scientific Title of Study
|
Validation of pediatric scale for quality of recovery (PedSQoR) in Hindi for pediatric orthopedic surgical patients |
| 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 Vinish Jain |
| Designation |
Junior resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9815311544 |
| Fax |
|
| Email |
vinish.jain28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Jindal |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004171 |
| Fax |
|
| Email |
swatirohitjindal604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinish Jain |
| Designation |
Junior resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9815311544 |
| Fax |
|
| Email |
vinish.jain28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, Pin Code- 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, Pin Code- 160030 |
| Type of Sponsor |
Government 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 Vinish Jain |
Government Medical College and Hospital, Chandigarh |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, Pin Code- 160030
Chandigarh
CHANDIGARH |
9815311544
vinish.jain28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GMCH, CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1.Pediatric patients aged 2–17 years with American Society of Anaesthesiologists physical status (ASA-PS) I–III.
2.Undergoing elective orthopedic surgery under general anaesthesia.
3.Children aged more than/equal to 7 years, able to provide assent and comprehend, will complete the PedSQoR as self-report. For children less than 7 years or those unable to self-report reliably, the primary caregiver will complete the scale as a proxy.
|
|
| ExclusionCriteria |
| Details |
1.Parent or patient refusal to provide informed consent or assent
2.Obvious cognitive or sensory impairments or developmental delay in neurodevelopmental milestones.
3.Presence of systemic diseases
4.Emergency surgery or surgery under regional anaesthesia
5.Parents, guardians, or patients who the investigator believes may not be available to complete the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validity and reliability of the Hindi-translated pediatric scale for quality of recovery (PedSQoR) in pediatric patients undergoing orthopedic surgery |
72 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Validity and reliability of the Hindi-translated pediatric scale for quality of recovery (PedSQoR) in pediatric patients undergoing orthopedic surgery at additional post-operative time points. |
At 24 hours, 48 hours, 96 hours post-operatively and the first post-operative OPD visit. |
| To evaluate the acceptability and feasibility of the Hindi PedSQoR, including completion rates, time to complete, and ease of understanding by pediatric patients and caregivers. |
At 24 hours, 48 hours, 72 hours, 96 hours post-operatively and the first post-operative OPD visit. |
| To investigate potential floor and ceiling effects that may affect the distribution and interpretability of scores. |
At 24 hours, 48 hours, 72 hours, 96 hours post-operatively and the first post-operative OPD visit. |
| To analyze concordance between self-reported scores by children aged 7 years and above and proxy reports from caregivers for younger children. |
At 24 hours, 48 hours, 72 hours, 96 hours post-operatively and the first post-operative OPD visit. |
| To collect perioperative clinical data including, rescue analgesia use, and incidence of postoperative nausea and vomiting to enhance the recovery assessment. |
At 24 hours, 48 hours, 72 hours, 96 hours post-operatively and the first post-operative OPD visit. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/01/2026 |
| 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="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
|
This study aims to
validate the Pediatric Quality of Recovery Scale (PedSQoR) in Hindi for
children undergoing orthopedic surgery. PedSQoR is a questionnaire designed to
measure recovery after surgery, including physical and mental well-being. The PedSQoR will be translated according to the
established cross-cultural adaptation guidelines which include backward
translation, forward translation, expert committee review, pilot testing and
psychometric validation of the PedSQoR in Hindi. The
study will include 110 pediatric patients aged 2–17 years. Children aged 7
years or older will complete the questionnaire themselves, while caregivers
will complete it for younger children. Alongside the PedSQoR, Global Health Numerical Rating Scale (NRS) and the Visual Analogue
Scale (VAS) for pain will be assessed to assess convergent validity of the Hindi PedSQoR. Assessments will be done at multiple
postoperative time points to evaluate the reliability, validity, feasibility,
and acceptability of the Hindi version. This study will provide a culturally
appropriate tool to assess postoperative recovery and improve perioperative
care for Hindi-speaking pediatric patients. This will make the PedSQoR easily
comprehensible and acceptable to children and their families who speak Hindi,
guaranteeing that the information gathered accurately represents their
experience of recovery. Participation involves only
completing the questionnaire, with no interventions or additional procedures.
AIM
To validate
the pediatric scale for quality of recovery (PedSQoR) in Hindi for pediatric
orthopedic surgical patients.
OBJECTIVES
Primary Objective
To assess the psychometric properties (validity,
reliability) of the Hindi-translated PedSQoR in pediatric patients undergoing
orthopedic surgery at 72h post-operative.
Secondary
Objectives
1. To assess the psychometric properties (validity, reliability) of
the Hindi-translated PedSQoR in pediatric patients undergoing orthopedic
surgery at 24h, 48h, 96h and the first post-operative OPD visit.
2. To evaluate the acceptability and feasibility of the Hindi
PedSQoR, including completion rates, time to complete, and ease of
understanding.
|