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CTRI Number  CTRI/2024/07/071489 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare effect of virtual reality glasses versus intravenous injection midazolam on anxiety in patients undergoing surgery under regional anesthesia . 
Scientific Title of Study   Comparison of virtual reality glasses versus intravenous injection midazolam on anxiety in patients undergoing surgery under regional anaesthesia : A randomised controlled study 
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. Meeraben Chauhan 
Designation  First year resident doctor 
Affiliation  Government Medical College Bhavnagar 
Address  Department Of Anaesthesia, Government medical College,Bhavnagar, Gujarat Bhavnagar Gujarat 364001 India
Sir T Hospital Kalanala road Bhavnagar Gujarat 364001
Bhavnagar
GUJARAT
364001
India 
Phone  7778069588  
Fax    
Email  meerachauhan3199@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Lopa Trivedi 
Designation  Associate Professor and HOD 
Affiliation  Government Medical College Bhavnagar 
Address  Department of Anaesthesia, Government medical College,Bhavnagar, Gujarat Bhavnagar Gujarat 364001 India
Sir T Hospital Kalanala road, Bhavnagar, 364001, Gujrat.
Bhavnagar
GUJARAT
364001
India 
Phone  9428009958  
Fax    
Email  trivedi_lopa@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Lopa Trivedi 
Designation  Associate Professor and HOD 
Affiliation  Government Medical College Bhavnagar 
Address  Department of Anaesthesia, Government medical College,Bhavnagar, Gujarat Bhavnagar Gujarat 364001 India
Sir T Hospital Kalanala road, Bhavnagar, Gujarat, 364001
Bhavnagar
GUJARAT
364001
India 
Phone  9428009958  
Fax    
Email  trivedi_lopa@yahoo.in  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANESTHESIOLOGY,Government medical college ,bhavnagar-364001 , gujarat, india 
 
Primary Sponsor  
Name  Meera chauhan 
Address  Department of Anaesthesia, Government medical College,Bhavnagar, Gujarat Bhavnagar GUJARAT 364001 India 
Type of Sponsor  Other [Self] 
 
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 Meeraben chauhan  Sir T Hospital   Main operation theater,above blood bank,Ortho operation theatre,Gopnath maternity hospital.
Bhavnagar
GUJARAT 		 7778069588

meerachauhan3199@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Government Medical college,Bhavnagar  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: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  application of virtual reality glasses  Virtual reality is distraction or diversion tool which has been useful in reducing the anxiety , decreasing pain levels and improving patient’s comfort levels during intraoperative periods . Virtual reality reduces procedural anxiety by reducing patient’s attention into the computer generated world , as the vitual reality “ transports” the patient from clinical settings to another “ reality” We will use this glasses for surgery duration upto 1 -1.5 hour. 
Comparator Agent  injection midazolam  Injection midazolam is belongs to group of benzodiazepines. It’s seadtive & anxiolytic property is useful in patients undergoing surgeries under regional anasthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients age between 18 to 60 years undergoing surgery
under regional anaesthesia
2.Patients having ASA (American
society of anaesthesiology) physical status I,II and
III
3.Surgery duration: maximum 1 hour  
 
ExclusionCriteria 
Details  1.Patients with known psychiatric disorders
2. Patients with audio visual impairment 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Assess the effect of virtual reality glasses
versus intravenous injection midazolam on
anxiety levels in patients undergoing surgery
under regional anaesthesia perioperative period
using Spielberger State-Trait Anxiety Inventory-6
(STAI-6) score. 		 PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare the following parameters in both the
groups:
Systolic blood pressure ( SBP) mmhg
Diastolic blood pressure (DBP) mmhg
Mean arterial pressure (MAP) mmhg
Heart rate ( HR) per minute
Respiratory rate (RR) per minute
Blood oxygen saturation ( SpO2 %)
Patient satisfaction score
Total dose of midazolam (mg/kg)
Complications & side-effects if any 		 PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   10/09/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Virtual reality is distraction or diversion tool which has been useful in reducing the anxiety , decreasing pain levels and improving patient’s comfort levels during intraoperative periods . Virtual reality reduces procedural anxiety by reducing patient’s attention into the computer generated world , as the virtual reality “transports” the patient from clinical settings to another “ reality”.
 Aim : To Assess the comparision of virtual reality glasses versus intravenous injection midazolam on anxiety in patients undergoing surgery under regional anaesthesia.
ʉۢStudy Design : Randomized controlled study.
 â€¢Study Population : Patients undergoing surgery under regional anaesthesia between 18 – 60 years of age. •Study Duration : 15 months 
. •Duration of Data collection : 12 months . 

•Sample Size : 52 (26 in each group)
 Sampling method : Simple random sampling
•The patients will be allocated to respective groups by computer generated random sequence numbers.
ʉۢV GROUP : Patients in this group will receive the virtual reality glasses.
ʉۢM GROUP : Patient in this group will receive the midazolam (0.02 mg/kg, maximum:- 2.5 mg) intravenously and is a control group.
 Anxiety score will be measured preoperatively, intraop and  after 15 min, after 30 min. after 45 min after 60 min andpostop Analysis will be done using appropriate method.
 
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