| CTRI Number |
CTRI/2025/07/090288 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Validation of Hindi version of picture form quality of recovery-15 scale in children undergoing surgery |
|
Scientific Title of Study
|
Psychometric validation of pictorial adaptation of the Hindi quality of recovery-15 scale in paediatric surgery patients; a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukhyanti Kerai |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
Department of Anaesthesiology & Intensive Care, 413, 4th floor, BL Taneja Block, Maulana Azad Medical College New Delhi
2 Bahadur Singh Zaffar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukhyanti Kerai |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
Department of Anaesthesiology & Intensive Care, 413, 4th Floor, BL Taneja Block, Maulana Azad Medical College New Delhi
2 Bahadur Singh Zaffar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukhyanti Kerai |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
Department of Anaesthesiology & Intensive Care, 413, 4th Floor, BL Taneja Block, Maulana Azad Medical College New Delhi
2 Bahadur Singh Zaffar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated hospitals |
| Address |
2 Bahadur Shah Zaffar Marg New Delhi |
| 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 |
| Sukhyanti Kerai |
Lok Nayak Hospital |
Paediatric Surgery Ward, Surgical block, 5th floor,
2 JLN Marg New Delhi
Central
DELHI |
9968527122
drsukhi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Maulana Azad Medical College New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
: Paediatrics patients scheduled to undergo elective surgery under general anaesthesia
Inclusion criteria
1. Age between 7 to 17 years
2. American Society of Anesthesiologists physical status I, II & III
|
|
| ExclusionCriteria |
| Details |
1. Severe cognitive or sensory impairments
2. Anticipated need for postoperative mechanical ventilation
3. Inability to understand Hindi language
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validity of Hindi quality of recovery-15 scale |
Validity of Hindi quality of recovery-15 scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reliability of Hindi quality of recovery-15 scale |
one day before and one day after surgery |
| Responsiveness for each question of Hindi quality of recovery-15 scale |
one day before and one day after surgery |
| Acceptability and feasibility of quality of recovery-15 scale |
one day before and one day after surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
16/07/2025 |
| 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 - Study Protocol
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsukhi25@gmail.com].
- For how long will this data be available start date provided 02-06-2026 and end date provided 02-06-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective observational study will be conducted on 150 paediatric patients scheduled to undergo elective surgery under general anaesthesia. Patients will be asked to complete the Hindi Pictorial version of quality of recovery scale -15 one day before and one day after the surgery. On postoperative day one overall postoperative recovery using a 100 mm VAS will also be assed. The validity, realibility, responsiveness and accebility of this scale will be assessed. |