| CTRI Number |
CTRI/2020/11/028906 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
26/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Preoperative Stress and Anxiety in Patients undergoing Elective Surgery under Regional and General Anaesthesia |
|
Scientific Title of Study
|
Assessment of Preoperative Stress,Anxiety and Predictive Factors in Patients Undergoing Elective Surgery Under Regional and General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishita Kaushal |
| Designation |
Junior Resident |
| Affiliation |
Dr RPGMC tanda |
| Address |
Department of Anaesthesia
Ot Complex 4th floor
Dr Rajendra Prasad Government Medical College,Kangra at Tanda
Department of Anaesthesia
Ot Complex 4th floor
Dr Rajendra Prasad Government Medical College,Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8219989150 |
| Fax |
|
| Email |
drnishi2909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishita Kaushal |
| Designation |
Junior Resident |
| Affiliation |
Dr RPGMC tanda |
| Address |
Department of Anaesthesia
Ot Complex 4th Floor
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Department of Anaesthesia
Ot Complex 4th Floor
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8219989150 |
| Fax |
|
| Email |
drnishi2909@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishita Kaushal |
| Designation |
Junior Resident |
| Affiliation |
Dr RPGMC tanda |
| Address |
Department of Anaesthesia
Ot Complex 4th Floor
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Department of Anaesthesia
Ot complex 4th Floor
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8219989150 |
| Fax |
|
| Email |
drnishi2909@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Ot complex 4th Floor
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Deptt. of Anaesthesia, DRPGMC, Kangra at Tanda |
| 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 Shelly Rana |
Dr Rajendra Prasad Government Medical College |
Department of Anaesthesia, Operation Theater complex
4th Floor
Kangra
HIMACHAL PRADESH |
9418113786
shelkbj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC tanda Kangra |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z000||Encounter for general adult medical examination, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA grade 1 to 3 scheduled for elective surgery under regional or general anaesthesia |
|
| ExclusionCriteria |
| Details |
Emergency operation
Reduced mental status of patient
History of psychiatric disdorder
Chronic sedative medication
Revision of previous operation
Patients undergoing long lasting treatment
Failure to give written and informed consent |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Stress ,Anxiety and factors in Patients undergoing Elective Surgery Under Regional and General Anaesthesia |
One Day Before Surgery and Half an Hour prior to Induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Stress ,Anxiety and Factors in Patients undergoing Elective Surgery under Regional and General Anaesthesia |
One day prior to surgery and half an hour prior to induction |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
17/11/2020 |
| 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="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All The patients anxiety level will be assessed utilizing questionnaire having the Amsterdam Preoperative Anxiety and Information Scale (APAIS) translated in Hindi /English language and visual analogue scale for anxiety (VAS-A). The VAS-A is based on a 100 mm scale with zero anxiety on the far left and maximum preoperative anxiety on the far right. A higher score indicates higher anxiety. The APAIS consists of six items on two scales: APAIS-Anxiety (four items) and APAIS-Need-for-Information (two items). APAIS-Anxiety has two subscales: Anxiety about Anaesthesia (two items) and Anxiety about Surgery (two items). Patients having APAIS < 11will be considered to be non anxious , while patients with anxiety (≥ 11 on the APAIS-Anxiety scale ) are considered anxious.9 The anaesthesia/surgery related anxiety will be further evaluated by the Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) questionnaire using a five-point Likert scale (1, never; 2, low; 3, moderate; 4, strong; 5, extreme).10 The patients will be assessed twice, one day prior to surgery while doing scheduled pre anaesthetic visit and half an hour prior to induction. The patients will be educated about the anaesthesia technique during pre anaesthetic visit and will be premedicated with tablet alprazolam 0.25mg at night prior and 6am in the morning of surgery. The patients will be provided anaesthesia as per the standard of care protocol of institution at the discretion of the attending anaesthesiologist. |