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CTRI Number  CTRI/2021/04/032673 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 05/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Randomised study to know the effectiveness of anaesthesia information sheet on pre-operative anxiety 
Scientific Title of Study   Effect of pre-operative communication using anaesthesia information sheet on pre-operative anxiety of patients undergoing elective surgery- A randomized control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR UTPALA KHAROD 
Designation  PRINCIPAL INVESTIGATOR 
Affiliation  H.M.PATEL INSTITUTE  
Address  ANAESTHESIA DEPARTMENT, SHRI KRISHNA HOSPITAL, H.M.PATEL INSTITUTE, BHAIKAKA UNIVERSITY, KARAMSAD

Anand
GUJARAT
388325
India 
Phone  9825318749  
Fax    
Email  utpala_kharod@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  SUTARIA KRUPA KIRITKUMAR 
Designation  RESIDENT 
Affiliation  H.M.PATEL INSTITUTE 
Address  DEPARTMENT OF ANESTHESIOLOGY, SHRI KRISHNA HOSPITAL, H.M.PATEL INSTITUTE, KARAMSAD, 388325

Anand
GUJARAT
388325
India 
Phone  9909784164  
Fax    
Email  krupa.sutaria@gmail.com  
 
Details of Contact Person
Public Query  
Name  SUTARIA KRUPA KIRITKUMAR 
Designation  RESIDENT 
Affiliation  H.M.PATEL INSTITUTE 
Address  DEPARTMENT OF ANESTHESIOLOGY, SHRI KRISHNA HOSPITAL, H.M.PATEL INSTITUTE, KARAMSAD, 388325

Anand
GUJARAT
388325
India 
Phone  9909784164  
Fax    
Email  krupa.sutaria@gmail.com  
 
Source of Monetary or Material Support  
H.M.Patel Institute, Shree Krishna Hospital 
 
Primary Sponsor  
Name  SHRI KRISHNA HOSPITAL 
Address  H.M.PATEL INSTITUE, SHRI KRISHNA HOSPITAL, KARAMSAD 
Type of Sponsor  Research institution and hospital 
 
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 
krupa sutaria  shree krishna hospital  Department of anaesthesia, H.M.Patel institute, shree krishna hospital , karamsad, anand
Anand
GUJARAT 		 19909784164
-
krupa.sutaria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H.M.Patel center for medical care and education  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Patients undergoing elective surgery whi are counselled conventionally  randamised trial will be conducted whether people counselled using anaesthesia information sheet and different level of anxiety than those counselled conventionally 
Intervention  randamised control trialabout using an anaesthesia information sheet in reducing pre operative anxiety  randamised trial will be conducted whether people counselled using anaesthesia information sheet have different level of anxiety than those counselled conventionally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient undergoing major elective surgeries(general surgeries – open and laproscopic hernioplasty,open and laproscopic appendisectomy, hydrocele, open and laproscopic cholecystectomy, speciality surgeries – turp , turbt , mrm , tkr , thr , popliteofemoral bypass, ortho surgeries – radius ulna platting/nailing , pfn , femur sirus nailing , tibia nailing/platting , clavicle platting , rotator cuff repair , arthoscopic knee repair , ob-gy surgeries – ah , lavh , vh , ent surgeries – septoplasty , fess , ear surgeries , dcr).

Patients aged 18-70 years of either sex.

Patients having American society of anesthesiology -ASA grade I-III Physical status.

patients who have studied minimum till standard 5.

patients understanding one of the languages from Gujarati, Hindi and English. 
 
ExclusionCriteria 
Details  patients having known psychiatric disorder.

patients taking anti-anxiety drugs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pre operative anxiety is still unrecognized entities in large number of cases. The results of this study will help us establish whether information sheet and thus visual alongwith verbal communication is useful in reducting anxiety in patients. If it is reliable approach to reduce stress and anxiety and provide comfortable ambience to patient.
 		 Pre operative anxiety will be reassessed after 2 hours of counseling.  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/04/2021 
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="1"
Months="0"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  As hard copies in the department

  6. For how long will this data be available start date provided 10-02-2021 and end date provided 31-08-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The study is randomised control trial. Study recruitment would be carried out after ethical approval. Written and informed consent would be taken from participant meeting inclusion and exclusion criteria and will. e randamized into either intervention (group S) or control group (group C).
Preoperative anxiety will be assessed in participants on the day prior to surgery.
Before participants are approached by us, the impression of the participants anxiety level would be rated by the staff nurses using the visual facial anxiety scale.
Pre-operative anxiety will be assessed by using 2 questionnarire visual anxiety scale:
1. VAS for fear of anaesthesia
2. VAS for fear of surgery
Visual anxiety scale questions are rated from 0 to 100, in which 0 means no anxiety and 100 means maximum anxiety.
This would be followed by the question "Are you afriad of anything at present?" IF report Yes, the participant would be asked to elaborate what things they are afriad of? Participant responses would be noted.
Participants in group S would be counselled using an ’anaesthesia information sheet’. This anaesthesia information sheet has details about meaning of anaesthesia, the preparation for anaesthesia, different types of anaesthesia and pros and corns of each method and post-operative care. This would be followed by clarification of the queries using counselling. That i have attached after performa. 
Participants in group C will be given information about anaesthesia as per standard of care.
After an interval of 2 hours, anxiety will be reassessed in both the study groups using the 2 quetionnare visual anxiety scale and if VAS score is more than 4 in any of the group, patients will be advised anti anxiety drugs.
 
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