| CTRI Number |
CTRI/2023/07/055049 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
09/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
EVALUATION OF PREOPERATIVE ANXIETY IN PATIENTS UNDERGOING NON EMERGENCY SURGERIES |
|
Scientific Title of Study
|
EVALUATION OF PREOPERATIVE ANXIETY IN ELECTIVE SURGICAL PATIENTS: A DESCRIPTIVE CROSS SECTIONAL 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 |
Gail Monica Richard |
| Designation |
post graduate student |
| Affiliation |
St Johns Medical College |
| Address |
St Johns Medical College,Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9629762388 |
| Fax |
|
| Email |
gailmrichard13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik Jain |
| Designation |
Associate Professor |
| Affiliation |
St Johns Medical College |
| Address |
St Johns Medical College,Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9845513713 |
| Fax |
|
| Email |
karthikjain@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Gail Monica Richard |
| Designation |
post graduate student |
| Affiliation |
St Johns Medical College |
| Address |
St Johns Medical College,Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9629762388 |
| Fax |
|
| Email |
gailmrichard13@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College,Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034 |
|
|
Primary Sponsor
|
| Name |
GAIL MONICA RICHARD |
| Address |
St Johns Medical College,Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034 |
| Type of Sponsor |
Other [self funded ] |
|
|
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 Gail Monica Richard |
St Johns Medical College Hospital |
department of anesthesia Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA |
7736263777
gailmrichard13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St Johns Medical college and Hospital |
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 |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients aged 19 years or more posted for elective surgeries |
|
| ExclusionCriteria |
| Details |
1. Pregnant & lactating women
2. Patients with intellectual disability
3. Dementia/Alzheimer’s disease
4. ASA V patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of preoperative anxiety in elective surgical patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the factors associated with preoperative anxiety. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "234"
Final Enrollment numbers achieved (India)="234" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2023 |
| Date of Study Completion (India) |
30/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To estimate proportion of patients
with preoperative anxiety among those coming for pre anaethesia check up using
a APAIS scoring system. and also evaluating the factors associated with preoperative anxiety .Being aware of the patients’ anxiety and finding appropriate approaches
for their anxieties can be valuable. APAIS is an effective method to measure
patient anxiety and it might be beneficial to use during preoperative visits
and the need for such studies in Indian population is of great
significance Patient satisfaction and superior outcomes can be achieved
in this way.
|