| CTRI Number |
CTRI/2024/05/067732 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hindi translation and validation of QOR-15 score |
|
Scientific Title of Study
|
Cross-cultural adaptation and psychometric analysis of the hindi version
of the Quality of Recovery-15 score in adult surgical 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 |
VANDANA JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Nehru Hospital, Anaesthesia office, 4th floor, Department of Anaesthesia and Intensive Care , Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7015107949 |
| Fax |
|
| Email |
j17vandana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varun Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anesthesia and Intensive Care, Nehru hospital, 4th floor, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988882149 |
| Fax |
|
| Email |
v.varunm88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VANDANA JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, 4th floor, Nehru hospital, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7015107949 |
| Fax |
|
| Email |
j17vandana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Postgradute Institute of Medical Education and Research |
| Address |
Sector 12, Chandigarh, 160012 |
| 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 |
| Vandana Jain |
Postgraduate Institute of Medical Education and Research |
Nehru hospital, 4th floor, Pre-anaesthesia room (preoperatively) and ward (in postoperative period)
Chandigarh
CHANDIGARH |
7015107949
j17vandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients greater than or equal to 18 years of age
2. Scheduled elective or emergency surgery
3. Availability for 24-hr post-operatively physically
4. Patients who are fluent in Hindi
|
|
| ExclusionCriteria |
| Details |
Patients who are not fluent in Hindi, Inability to obtain consent, Patient not expected to be able to answer the QoR-15 scale on post-operative day (POD) 1 (e.g., expected postoperative mechanical ventilation), Patient with a psychiatric condition expected to bias QoR-15 measures (e.g., delirium or other state of disorganized thinking), Known history of Alcohol or drug dependence
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cross-cultural adaptation and psychometric analysis of the Hindi version of the QOR-15 score in adult patients undergoing surgery |
Before surgery in the pre-operative room (t1) (i.e. on the day before or on the morning of the day of surgery) and 24 hours after the completion of surgery (t2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
30/05/2024 |
| 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="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
|
The original
Quality of Recovery-15 score was developed and validated in Australia in the English language. It might not be directly applicable in
Indian population with their significantly different cultural aspects and
perception of health. Considering these variations, a cross-cultural adaptation
and psychometric evaluation of a Hindi version of the QoR-15 is essential for a
wider application to the Indian population, whilst ensuring its validity in
this population. This study hypothesise that QoR-15H would have psychometric properties and
interpretability in assessing postoperative recovery similar to that of QoR-15
developed and validated in English-speaking populations. Primary purpose of the study is to translate and cross-culturally adapt the QoR-15 score
to hindi. |