| CTRI Number |
CTRI/2025/03/083394 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Compare the Anxiety Score in Patients Posted for Surgery. |
|
Scientific Title of Study
|
An Observational Cross-Sectional Study to Compare the Anxiety Scores in Patients Posted for Pre and Post surgery Surgery |
| 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 Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Jalaun(Orai) |
| Address |
Department of Anesthesia and Critical Care , Room number 8 Block H Type 3
Government Medical College Jalaun(Orai)
285001
Uttar Pradesh
India
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
dranilkumarucr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Ahirwar |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Jalaun(Orai) |
| Address |
Department of Anesthesia and Critical Care,
Flat 2, Block E, Type 4, GMC Jalaun(Orai)
Uttar Pradesh
India
Kalpi Road
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
7007344628 |
| Fax |
|
| Email |
arunrhythm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Ahirwar |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Jalaun(Orai) |
| Address |
Department of Anesthesia and Critical care , GMC Jalaun,
Flat 2, Block E, Type 4
Kalpi Road
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
7007344628 |
| Fax |
|
| Email |
arunrhythm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Jalaun(Orai) 285001
India
Uttar Pradesh
|
|
|
Primary Sponsor
|
| Name |
Dr Anil Kumar |
| Address |
Room No.8 Type3 Block H GMC Jalaun(Orai) 285001
Uttar Pradesh, India |
| Type of Sponsor |
Other [self] |
|
|
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 Anil Kumar |
Rajkiya Medical college , Orai, Jalaun |
Room Number 4, OT Complex GMC Jalaun(Orai)
Jalaun
UTTAR PRADESH |
9454224498
dranilkumarucr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMC Jalaun(Orai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K420||Umbilical hernia with obstruction,without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA Grade I to II
2 Ability to Speak and Understand Hindi and English Language |
|
| ExclusionCriteria |
| Details |
1 ASA IV
2 Emergency Cases
3 Psychiatric Illness or Mental Retardation
4 malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety level according to Amsterdam Preoperative Anxiety and Information Scale |
baseline
6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect on Anxiety of
1 sex
2 Education
3 Gender |
12 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Preoperative Anxiety in Surgical Patients imposes Stress and Dissatisfaction, The Study was conducted to determine the changes in Anxiety Level and need for information about Anesthesia and the Surgical Procedures at different time points before Surgery ,Assessed with Amsterdam Preoperative Anxiety and Information Scale at T1 at Preanesthetic Evaluation, and T2 on the day of surgery , in the Preoperative holding Area. Patients compared for Anxiety Score at 2 different time. |