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CTRI Number  CTRI/2024/06/069289 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 05/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of 3D video by special virtual reality headset for reduction of anxiety in children during general anaesthesia for surgery 
Scientific Title of Study   Effect of immersive virtual reality vs intranasal midazolam on preoperative anxiety in children undergoing inhalation induction of anaesthesia: A prospective, 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  Renu Sinha 
Designation  Professor 
Affiliation  Department of Anaesthesiology, Pain medicine and Critical care  
Address  Room no 376, 3rd floor, Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810305156  
Fax    
Email  renusinha@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Renu Sinha 
Designation  Professor 
Affiliation  Department of Anaesthesiology, Pain medicine and Critical care  
Address  Room no 376, 3rd floor, Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810305156  
Fax    
Email  renusinha@aiims.edu  
 
Details of Contact Person
Public Query
 
Name  Poojan Bhatt 
Designation  Junior resident  
Affiliation  Department of Anaesthesiology, Pain medicine and Critical care 
Address  Department of Anaesthesiology, Pain medicine and Critical care, AIIMS, New Delhi
Green Park main, new delhi
New Delhi
DELHI
110029
India 
Phone  9924036171  
Fax    
Email  dr.poojanbhatt@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  AIIMS, NEW DELHI  
Address  Department of Anaesthesiology, Pain medicine and Critical care, AIIMS, New Delhi, 110029 
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 
Dr Renu Sinha  AIIMS  Room no 376, 3rd floor, Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
South
DELHI 
9810305156

renusinha@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Immersive Virtual Reality   We will show videos in a VR headset to children 10 minutes before anaesthesia till induction of anaesthesia to reduce their preoperative anxiety 
Comparator Agent  Intranasal Midazolam   Midazolam is a benzodiazepine. It will be administered intranasally to children 20 minutes prior to induction of anaesthesia to reduce their preoperative anxiety  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ASA PS: I,II
surgery under general anaesthesia 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of immersive virtual reality (IVR) with intranasal midazolam on change in the preoperative anxiety (mYPAS) at inhalational induction of anaesthesia  From 20 minutes before surgery till induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare preoperative anxiety during shifting from preoperative room to operation theatre (OT)
2)To compare the mask acceptance between both groups.
3)To compare the ease of induction between both groups.
4)To compare the satisfaction of parent between both groups. 
1. 20 minutes before induction of anaesthesia in the preoperative room
2.10 minute before induction of anaesthesia in the preoperative room
3. 5 minutes before induction patient during shifting from preoperative room to the operation theatre
4. at the time of induction of anaesthesia 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/07/2024 
Date of Study Completion (India) 29/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/09/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 anxiety is very common in children which can lead issues at induction of anaesthesia and gives a traumatic experience to the child and dissatisfaction among parents.

Various pharmacological and non-pharmacological methods have been used to decrease the preoperative anxiety of the child. Among pharmacological methods, drugs such as midazolam, clonidine, and dexmedetomidine have been used via various routes. However, sedatives drugs may lead to some side effects. Non-pharmacological methods are based mostly on distraction tactics. These include merely talking to the child, or use of audio rhymes, cartoon videos etc.

Immersive virtual reality (IVR) is the latest development in technology of such kind and children seem to adapt to it quickly too. Hence we planned this study to evaluate the effect of IVR on decreasing the preoperative anxiety in children in OT with primary aim to compare the effect of immersive virtual reality (IVR) with intranasal midazolam  on change in the preoperative anxiety at inhalational induction of anaesthesia

After pre-anaesthetic check-up a day before surgery, aim and methodology of the study will be informed to parents and children above the age of 6 years and informed consent will be obtained. Child’s anxiety score (mYPAS) (Tp) will be noted. In the same visit, the VR headset will be checked for proper fitting. The child will choose his/her favourite video. On the day of surgery, the child will be randomised into group V or group M. Child’s mYPAS will be noted in the preoperative room. In group V, selected video via  IVR headset will be played in the preoperative room and he/she will be shifted to OT with the headset on and induction of anaesthesia will be done with face mask and inhalational agents while the child is watching the video via headset.In case of group M, 20 minutes prior to shifting to the OT, 0.3 mg/kg midazolam will be spayed into one nostril or divided doses into both nostrils. The child will be transferred to OT on a trolley and induction of anaesthesia will be done, with face mask and inhalational agents. In both groups, a parent or guardian will accompany the child to the OT according to the hospital policy.

The following steps will be common to both the groups. mYPAS scores will be noted a day before in the ward (Tp), before the initiation of intervention(T0), in the preoperative room at 10 minutes after intervention (T1), the time of transport to OT (T2) and during the induction of anaesthesia (T3). Standard ASA monitors will be attached & inhalational induction will be done with incremental increase in sevoflurane concentration in 100% O2, with an appropriately sized face mask. Assessment of Induction compliance checklist (ICC) and Mask acceptance score (MAS) will be done and noted. Insertion of IV cannula will be done once adequate depth of anaesthesia is achieved. Rest of the anaesthesia management including airway management will be at the discretion of the attending anaesthesiologist. Parent’s satisfaction will be assessed after induction of anaesthesia.

 
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