| CTRI Number |
CTRI/2021/10/037546 [Registered on: 25/10/2021] Trial Registered Prospectively |
| Last Modified On: |
13/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
“A study in a hospital in Chennai on Preoperative anxiety in adults who have to go for surgery †|
|
Scientific Title of Study
|
“Preoperative anxiety among adults undergoing surgery - A survey" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sree Ranjini |
| Designation |
Professor |
| Affiliation |
Bhaarath Medical College Hospital |
| Address |
HOD ROOM, Ist floor, Department of Anaesthesiology, Bhaarath Medical college Hospital, 173, Agaram main road, Selaiyur, Chennai No.173, Agaram main road, Selaiyur, Chennai Chennai TAMIL NADU 600073 India |
| Phone |
9840770817 |
| Fax |
|
| Email |
dr.s.sreeranjani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S Sree Ranjini |
| Designation |
Professor |
| Affiliation |
Bhaarath Medical College Hospital |
| Address |
HOD room, 1st floor, Department of Anaesthesiology, Bhaarath Medical college Hospital, 173, Agaram main road, Selaiyur, Chennai HOD ROOM, 1st floor, Department of Anaesthesiology,
173, Agaram main road, Selaiyur, Chennai Chennai TAMIL NADU 600073 India |
| Phone |
9840770817 |
| Fax |
|
| Email |
dr.s.sreeranjani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Sree Ranjini |
| Designation |
Professor |
| Affiliation |
Bhaarath Medical College Hospital |
| Address |
HOD ROOM, 1st floor, Department of Anaesthesiology, Bhaarath Medical college Hospital, 173, Agaram main road, Selaiyur, Chennai HOD ROOM, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY,
173, Agaram main road, Selaiyur, Chennai Chennai TAMIL NADU 600073 India |
| Phone |
9840770817 |
| Fax |
|
| Email |
dr.s.sreeranjani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaarath medical college hospital, 173, Agaram main road, Selaiyur, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr S Sree Ranjini |
| Address |
Department of Anaesthesiology, Bhaarath Medical college Hospital, 173, Agaram main road, Selaiyur, Chennai 600073 |
| Type of Sponsor |
Private 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 S Sree Ranjini |
Bhaarath Medical College Hospital |
Preoperative assessment room, Ist floor, Department of Anaesthesiology,173, Agaram main road, Selaiyur, Chennai 600073 Chennai TAMIL NADU |
9840770817
dr.s.sreeranjani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaarath Institutional ethics committee |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Adult Patients of ASA – PS classification I and II status above 18 years of age till 60 years undergoing any surgery requiring anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with ASA – PS classification III physical status or greater, Patients less than 18 years of age and more than 60 years of age, Unwilling patients, patients with psychiatric disorders on anti psychotic drugs, language or communication difficulties, renal or hepatic derangement, low intelligence quotient. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of preoperative anxiety, Level of anxiety |
Prevalence of preoperative anxiety, Level of anxiety, both as percentage at baseline using numerical rating scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of age, gender, type of surgery, previous surgery, education and socioeconomic status on pre-operative anxiety |
descriptive |
|
|
Target Sample Size
|
Total Sample Size="412" Sample Size from India="412"
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)
|
01/11/2021 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preoperative anxiety is described as an unpleasant
state of uneasiness or tension that is secondary to a patient being concerned
about a disease, hospitalization, anesthesia, and surgery, or the unknown. Preoperative anxiety if
unallayed is associated with intraoperative haemodynamic changes as well as
postoperative hemodynamic issues, psychological problems, delayed wound
healing, higher chances of infection etc. Though preoperative anxiety has so many negative
implications, it is often a neglected area. Hence on assessment of
the presence of anxiety and the level, adequate anxiolytic premedication can be
prescribed and thus avoid all the
complications associated with it. In addition, the relationship between
anxiety and age, gender, type of surgery, education and socioeconomic status
can be evaluated, as these may have an influence on the anxiety levels and
severity. The overall prevalence
of preoperative anxiety as reported in some studies is in range of 60–80% but
some researchers showed a wider range, which is 11–80%
There are many studies on the prevalence rates of
preoperative anxiety among western population, few in Indian population and none
on our local population in our area and hospital. Hence I planned to study the
same.
Aim
of the study: To
evaluate the Preoperative anxiety among adults undergoing surgery
Objectives
of the study:
·
Primary:
Prevalence of preoperative anxiety, Level of anxiety
·
Secondary
: Effect of age, gender, type of surgery, previous
surgery, education and socioeconomic status on pre-operative anxiety
Materials
and Methods:
·
Study design: Prospective, descriptive
·
Study Population:
Inclusion criteria: All Adult Patients of ASA – PS classification I and II status above 18 years
of age undergoing any surgery requiring anaesthesia
Exclusion criteria:
Patients with ASA – PS classification III physical status or greater, Patients
less than 18 years of age and more than 60 years of age, Unwilling patients,
patients with psychiatric disorders on anti‑psychotic drugs,
language or communication difficulties, renal or hepatic derangement, low
intelligence quotient.
·
Sampling Procedure: Research sample is taken from hospital patients who
require surgery and who fulfill inclusion and exclusion criteria.
To
calculate sample size I took Indian studies using similar assessment tests. A sample size of 412 patients is taken, determined
from previous studies, where the prevalence of preoperative anxiety was
computed to be around 58%. The sample size was determined by
using a single proportion for a finite population with assumptions of 95% confidence
level, marginal error (d) of 5% and the prevalence (P) of 58%, based on the
previous studies. So, this proportion
was used to determine the sample size.
n= Z2 p(1-p)/d2 Where:
n
= the desired sample size
Z
= standard normal score (at 95% confidence level) Where: Z = 1.96
P
= prevalence = (58%) = 0.58
D
= degree of accuracy desired marginal error (d) of 5% = 0.05
n
= 375.
Considering 10% non-response rate. So Sample size is 412
Benefits
of the study: On assessing presence of anxiety and its severity,
anxiety reduction methods can be employed to make it more pleasant for the
patient and for a better intra and post-operative outcome. For major surgery, preanaesthetic counselling can be given. |