| CTRI Number |
CTRI/2024/03/063652 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Preoperative anxiety and fear of Anaesthesia |
|
Scientific Title of Study
|
A Study on The Preoperative Anxiety and Fear of Anaesthesia using Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score in A Tertiary Care Hospital. (MVJ MC&RH) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Liqayatul Wadud Al Hadi |
| Designation |
Junior Resident |
| Affiliation |
MVJ Medical College and Research Hospital |
| Address |
Room no. 5, Major OT Complex, Department Of Anaesthesiology MVJ Medical College & Research Hospital
Hoskote Bangalore
Bangalore Rural
KARNATAKA
562114
India |
| Phone |
7795727015 |
| Fax |
|
| Email |
liqayatulwadudalhadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nirmala BC |
| Designation |
Professor |
| Affiliation |
MVJ Medical College and Research Hospital |
| Address |
Room no. 5, Major OT Complex, Department Of Anaesthesiology MVJ Medical College & Research Hospital
Hoskote Bangalore
Bangalore Rural
KARNATAKA
562114
India |
| Phone |
9341285491 |
| Fax |
|
| Email |
nirmalbc.prasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Liqayatul Wadud Al Hadi |
| Designation |
Junior Resident |
| Affiliation |
MVJ Medical College and Research Hospital |
| Address |
Room no. 11, Major OT Complex, Department Of Anaesthesiology MVJ Medical College & Research Hospital
Hoskote Bangalore
Bangalore Rural
KARNATAKA
562114
India |
| Phone |
7795727015 |
| Fax |
|
| Email |
liqayatulwadudalhadi@gmail.com |
|
|
Source of Monetary or Material Support
|
| MVJ Medical College and Research Hospital, Hoskote, Bangalore, Karnataka -562114 |
|
|
Primary Sponsor
|
| Name |
Liqayatul Wadud Al Hadi |
| Address |
MVJ Medical College and Research Hospital
Hoskote, Bangalore |
| 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 Liqayatul Wadud Al Hadi |
MVJ Medical College and Research Hospital |
OT Complex 5-11, 1st Floor, Department of Anaesthesiology
Bangalore Rural
KARNATAKA |
7795727015
liqayatulwadudalhadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJ Medical College and Research 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to ASA I (normal Healthy patient), ASA II (Patient with mild systemic disease) categories and ASA III (patients with severe systemic disease).
2. Patients posted for Elective surgery.
3. Who gave consent to participate in the study.
4. Who have adequate language skills to communicate.
|
|
| ExclusionCriteria |
| Details |
1. Children less than 18 years.
2. Patients with Mental retardation, Dementia, Alzheimer’s disease or other Psychiatric disorders.
3. Patients requiring emergency surgeries.
4. Patients in ASA in IV and above Categories
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on the results of the study, best strategies can be Identified and can be recommended to reduce preoperative anxiety and hence improving Intra operative and post operative outcome. |
Preoperative period and Postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
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)
|
15/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 preoperative
period which is the period before surgery is one of the most worrying events
for most surgical patients and is associated with deleterious effects like
tachycardia, hypertension, cardiovascular disturbances due to sympathetic
stimulation, and elevated Intraoperative cortisol levels. Other effects of
Preoperative anxiety were postoperative nausea and vomiting, increased
requirement of anaesthesia, increased risk of infection, augmented pain during the postoperative period, and many physical, psychiatric, and emotional problems
ultimately extending the recovery period and length of stay in the hospital. Hence based on
the results of the study, the best strategies can be Identified and recommended to reduce preoperative anxiety and hence improve intraoperative and postoperative outcomes.
|