FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
Close