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CTRI Number  CTRI/2024/04/065846 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 14/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Changes in patient satisfaction and anxiety levels, undergoing surgery with use of Audio-visual aids. 
Scientific Title of Study   Effect of Audio-visual aid on Preoperative anxiety and postoperative patient satisfaction in a rural teritiary care center. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinutha A P 
Designation  PG Student 
Affiliation  Sri Madhusudan Sai Institute of Medical Science and Research 
Address  Department of Anesthesiology, SMSIMSR, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103

Kolar
KARNATAKA
562103
India 
Phone  8082114033  
Fax    
Email  visionsworld2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vasudeva Upadhayaya 
Designation  Professor 
Affiliation  Sri Madhusudan Sai Institute of Medical Science and Research 
Address  Department of Anesthesiology, SMSIMSR, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103

Kolar
KARNATAKA
562103
India 
Phone  9611704281  
Fax    
Email  vasudeva.upadhyaya@smsimsr.org  
 
Details of Contact Person
Public Query
 
Name  Dr Nikhil M 
Designation  Assistant Professor 
Affiliation  Sri Madhusudan Sai Institute of Medical Science and Research 
Address  Department of Anesthesiology, SMSIMSR, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103

Kolar
KARNATAKA
562103
India 
Phone  7411403086  
Fax    
Email  docnikonly@gmail.com  
 
Source of Monetary or Material Support  
Sri Madhusudan Sai Institute of Medical Science and Research, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103 
 
Primary Sponsor  
Name  Sri Madhusudan Sai institute of medical science and research 
Address  Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103 
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 Nikhil M  Sri Madhusudan Sai institute of medical science and research  Pre Anaesthesia check up room no. 25, Department of Anaesthesiology,SMSIMSR,satya sai grama, muddenahalli, nandi hobli, chikkaballapur 562103
Kolar
KARNATAKA 
7411403086

docnikonly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Sri Satya Sai University for human excellence  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 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients belonging to American society of anaesthesiology(ASA) 1 & 2, age more than 18 years and less than 60 years undergoing elective surgery under regional anaesthesia 
 
ExclusionCriteria 
Details  1. Patient refusal to participate
2. Patients who have received anesthesia previously
3. Patients with impaired eyesight or hearing
4. Patients on anxiolytics and antidepressants
5. Patients with existing psychiatric disorder
6. Patients who are health care workers
7. Obstetric patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pre-operative anxiety using Amsterdam Preoperative Anxiety and Information sale(APAIS)   1 hour prior to surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction using 5-point Likert scale   post operative period day one - 24 hours 
 
Target Sample Size   Total Sample Size="71"
Sample Size from India="71" 
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)   14/05/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Majority of patients who are posted for surgery experience anxiety ¹. A lack of awareness about operation theatre environment and anaesthetic techniques can cause anxiety 2 , 3. Anxiety activates stress responses which in turn leads to increased blood sugar levels, suppression of cellular immune response, raised oxidative demand, tachycardia, raised blood pressure, delayed wound healing 4,5. Patients with anxiety require increased doses of anaesthetics and analgesics 6. Higher doses of induction agents, longer hospital stay, and high incidence of perioperative complications are seen in anxious patients 7. Therefore, information provided by the anesthesiologist during the Preanesthetic Interview (PAI) plays a crucial role in reducing anxiety and enhances better patient outcome 8. Pre anaesthetic interview serves as a good platform to establish patient doctor relationship which will be helpful for providing information about anaesthesia. This will bring forth better educated and informed patients 9.

India is a multilingual country. In rural areas most patients speak regional language and doctors may not know to communicate in regional language. This language barrier can cause poor communication, misinterpretation, dissatisfaction, and poor patient outcome. Not all patients are literate enough to read and understand an information form. Complexity of these forms may prevent patients from fully understanding the information provided or patients may simply refuse to read the material. Nonetheless, written information requires basic literacy skills and motivation to read the material.

With the technological advances, audio visual aids have become an essential part of our education and communication. Incorporating this in our standard health care services can help bridge the communication gap.  It can empower rural patients with knowledge and understanding of anaesthesia which in turn reduces anxiety and improve patient satisfaction.
            Primary aim of the study will be to assess the impact of standard preanaesthesia verbal instructions versus verbal instructions and audio-visual aid on anxiety during preoperative period.

Secondary aim will be to assess postoperative satisfaction in both the groups

 
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