| CTRI Number |
CTRI/2025/03/082423 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
TO ASSESS PRE OPERATIVE ANXIETY AND VARIOUS FACTORS IN PATIENTS UNDERGOING SURGERY
UNDERGOING SURGERY IN REGIONAL AND GENERAL ANAESTHESIA
AN OBSERVATIONAL STUDY
|
|
Scientific Title of Study
|
ASSESSMENT OF THE PRE-OPERATIVE STRESS & ANXIETY AND THE PREDICTIVE FACTORS IN PATIENTS UNDERGOING ELECTIVE AND EMERGENCY SURGERY UNDER REGIONAL AND GENERAL ANAESTHESIA
AN 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 |
Eesha |
| Designation |
Junior resident |
| Affiliation |
|
| Address |
Department of anesthesiology, Dr RPGMC Tanda at Kangra (H.P.)
Bilaspur
HIMACHAL PRADESH
176001
India |
| Phone |
8219829767 |
| Fax |
|
| Email |
eeshabatrarocks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor & HOD |
| Affiliation |
Dr RPGMC Tanda at Kangra(H.P.) |
| Address |
Dept. Of Anesthesiology, Dr RPGMC Tanda at KANGRA (H.P.)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor & HOD |
| Affiliation |
Dr RPGMC Tanda at Kangra(H.P.) |
| Address |
Dept. Of Anesthesiology, Dr RPGMC Tanda at KANGRA (H.P.)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Medical superintendent office room no. 203 first floor block A, Dr RPGMC Kangra at Tanda, distt. Kangra (H.P.) |
|
|
Primary Sponsor
|
| Name |
Eesha batra |
| Address |
Dept. Of Anesthesiology , Dr RPGMC Kangra at Tanda (H.P.) 176001 India |
| 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 Eesha batra |
Dr RPGMC Kangra hospital at Tanda Himachal pradesh |
Operation theatre complex 3rd floor Department of Anesthesiology , Dr RPGMC Kangra at Tanda (Himachal pradesh )
Kangra
HIMACHAL PRADESH |
8219829767
eeshabatrarocks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe , Dr RPGMC Tanda at Kangra(H.p.) |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients belonging to ASA I/III aged 18-80 years , scheduled for emergency and elective under regional / general anaesthesia |
|
| ExclusionCriteria |
| Details |
Reduced mental status, ASA more than IV, history of psychiatric disorder , chronic sedative abuse, revision of previous surgery, failure to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess preoperative anxiety in patients undergoing elective and emergency surgeries |
Before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To score preoperative anxiety in patients based on various scores |
Before surgery |
|
|
Target Sample Size
|
Total Sample Size="334"
Sample Size from India="334"
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)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2025 |
| 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 Applicable |
| 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 goal of this thesis is to assess pre operative anxiety in various patient groups and predictive factors based on various scores and scale |