| CTRI Number |
CTRI/2016/08/007214 [Registered on: 19/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of anxiety in patients undergoing surgery |
|
Scientific Title of Study
|
Audit of anxiety levels in preoperative period in surgical patients in medical institute |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerana Nirav Shah |
| Designation |
Professor (Additional) |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai 400012, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869117027 |
| Fax |
|
| Email |
pps@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Prerana Nirav Shah |
| Designation |
Professor (Additional) |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai 400012, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869117027 |
| Fax |
|
| Email |
pps@kem.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prerana Nirav Shah |
| Designation |
Professor (Additional) |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai 400012, Maharashtra
MAHARASHTRA
400012
India |
| Phone |
9869117027 |
| Fax |
|
| Email |
pps@kem.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai 400012, Maharshtra |
| Type of Sponsor |
Other [] |
|
|
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 Prerana Nirav Shah |
GSMC & KEMH |
Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9869117027
PPS@KEM.EDU |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult ASA 1 and 2
Age between 18 -65 years
Undergoing various elective surgeries
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult ASA 1 and 2
Age between 18 -65 years
Undergoing various elective surgeries
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Transplant surgery
Neurological diseases
Aged under 18 or older than 65
Known psychiatric illness
Patients on anxiolytic medication
Those unable to read
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate reduction in anxiety levels on the day before surgery as regards to the information known by the patient regarding the diagnosis, surgical procedure, and anesthesia before preoperative assessment and after providing them the information for the same |
Before pre-anaesthetic assessment on the day prior to surgery before visiting hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the factors responsible for preoperative
anxiety in surgical patients in Hospital |
Before pre-anaesthetic assessment on the day prior to surgery before visiting hours |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2014 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anxiety is common in surgical patients during the preoperative period. High levels of preoperative anxiety may have unfavorable effects on induction and maintenance of anaesthesia as well as on the recovery from anaesthesia and surgery. Anxious patients may require higher doses of anaesthetic induction agents and postoperative analgesic drug. Primary Objective: To evaluate reduction in anxiety levels on the
day before surgery as regards to the information known by the patient regarding
the diagnosis, surgical procedure, and anesthesia before preoperative assessment and after providing
them the information for the same
Secondary Objective: To determine the factors responsible for
preoperative anxiety in surgical patients in Hospital After noting basic demography, SECTION
1 of questionaire consists of three questions to know the information patients have about the
diagnosis, upcoming surgery procedure, type of anesthesia to be provided while SECTION 2 has a list of 16 questions relating to
anxiety. The participants will select different factors responsible for their
anxiety from this list. The level of patients’ anxiety assessed with the visual
analogue scale (VAS). Each
participant will in addition be requested to make an assessment of average
personal level of anxiety to be assessed by VAS score. The patient will be randomly allotted one of
the two groups. The study group and control group. The study group will receive
the information about the diagnosis, the surgery to be performed, and the type
of anaesthesia. The control group will not be given any information.
The average personal level of anxiety of the
patient will again be assessed with VAS score in both the groups. To find out the incidence of preoperative
anxiety by VAS of the 16 factors. A score of at least 45mm on the VAS will be regarded as significant anxiety
for each factor Maximum value -1500 Minimum value- 0 Significant anxiety-675
To determine the influence of gender, age,
educational level and previous surgical treatment on anxiety using appropriate
statistical tests. The study will be conducted in 84 subjects and appropriate statistical analysis will be done. |