FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056014 [Registered on: 02/08/2023] Trial Registered Prospectively
Last Modified On: 24/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of distraction using virtual reality and augmented reality tools for reduction of anxiety of surgery in children.  
Scientific Title of Study
Modification(s)  		 Comparative evaluation of virtual reality and augmented reality as distraction techniques on preoperative anxiety in pediatric patients.  
Trial Acronym  Pard trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Garvita Bhatnagar 
Designation  Post graduate student 
Affiliation  Maulana azad medical college 
Address  Department of Anaesthesiology, Room No 308, BL Taneja Block, Maulana azad Medical college and associated hospitals, 2, bahardur shah zafar marg, near delhi gate, New Delhi
2, bahadur shah zafar marg, near Delhi gate, New Delhi-110002
Central
DELHI
110002
India 
Phone  8095315303  
Fax    
Email  garvitabhatnagar5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kapil Chaudhary  
Designation  Professor  
Affiliation  Maulana azad medical college 
Address  Room number-313, 3rd floor B.L Taneja block, Maulana azad medical college, bahadur shah zafar road, New Delhi

Central
DELHI
110002
India 
Phone  9968604504  
Fax    
Email  kapsdr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Garvita Bhatnagar  
Designation  Post graduate student  
Affiliation  Maulana azad medical college 
Address  Department of Anaesthesiology,Room No 308, BL Taneja Block, Maulana azad medical college, New Delhi

Central
DELHI
110002
India 
Phone  8095315303  
Fax    
Email  garvitabhatnagar5@gmail.com  
 
Source of Monetary or Material Support  
Maulana azad medical college, 2 bahadur shah zafar marg, New Delhi- 110002 
 
Primary Sponsor  
Name  Maulana azad medical college 
Address  Department of Anaesthesiology and Intensive care Maulana Azad Medical College New Delhi- 110002 
Type of Sponsor  Government 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 Garvita Bhatnagar   Lok nayak and associated hospitals   OT Blocks, Department of Anaesthesiology, Maulana azad medical college and assocaited hospitals, New Delhi, bahadur shah zafar marg, New Delhi- 110002
Central
DELHI 		 8095315303

garvitabhatnagar5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, maulana azad medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: H028||Other specified disorders of eyelid, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Augmented reality   Augmented reality application will be shown to measure change in anxiety from preoperative area till induction of anaesthesia. 
Comparator Agent  Virtual reality  virtual reality headset will be shown to child to measure change in anxiety from preoperative area till induction of anesthesia.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  ASA physical status I-III. 
 
ExclusionCriteria 
Details  1.Patients with injuries to head and face that would interfere in wearing headsets.
2. Skin infections and open wounds on face/head.
3. Inability to visualise AR/VR applications.
4. Patients in whom VR headsets do not fit appropriately. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in preoperative anxiety (mYPAS score).  Baseline to induction. 
 
Secondary Outcome  
Outcome  TimePoints 
Pediatric induction compliance using induction compliance checklist score.  During induction of general anaesthesia. 
Parental anxiety using state trait anxiety inventory score. (STAI)  after induction.  
Parental satisfaction using parental & patient satisfaction scores  after induction 
Time to loss of eyelash reflex  after induction till loss of eyelash reflex 
Time to central miosis  after induction till central miosis 
Change in preoperative anxiety using mYPAS score.  during induction. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/08/2023 
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   Preoperative pediatric anxiety is common and can have negative psychological impact on children undergoing anaesthesia and surgery. Various audiovisual distraction techniques like Virtual reality have proven to be effective in lowering anxiety as assessed my modified yale perioperative scale(mYPAS). Augmented reality is a newer, interactive technology that allows users to simultaneously view the real world environment with digital image overlay. The aim of our study is to evaluate and compare virtual reality and augmented reality in pediatric patients aged 4-10 years old.
Our primary outcome is to assess change in preoperative anxiety from baseline to induction using mYPAS scale. Our secondary outcomes are to measure pediatric induction compliance using induction compliance checklist score, parental anxiety using state trait anxiety inventory score, parental satisfaction using parental and patient satisfaction questionnaires, time to loss of eyelash reflex and time to central miosis. 
 
Close