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CTRI Number  CTRI/2025/09/094898 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The effect of a novel device on pain during venous line placement in children aged 7 -12 years 
Scientific Title of Study   Effects of an immersive virtual reality Intervention on pain and anxiety during venipuncture in children aged 7-12 years-a three arm concurrent parallel design randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vangeti Rohitha Reddy 
Designation  Postgraduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Pediatrics, Hospital Block, Sri Balaji Vidyapeeth University Campus, Pillayarkuppam, Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9502234455  
Fax    
Email  rohithareddy459@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikneswari Karthiga S 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Pediatrics, Hospital block, Mahatma Gandhi Medical College and Research Institute, SBV Campus, Pillayarkuppam , Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9486899335  
Fax    
Email  dr.vikneswari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vangeti Rohitha Reddy 
Designation  Postgraduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Pediatrics, Hospital Block, Mahatma Gandhi Medical College and Research Institute, SBV Campus, Pillayarkuppam , Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9502234455  
Fax    
Email  rohithareddy459@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mahatma Gandhi medical College and Research Institute,Sri Balaji Vidyapeeth University 
Address  SBV Campus, Pillayarkuppam, Puducherry- 607402 
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 Vangeti Rohitha Reddy  Mahatma Gandhi Medical College and Research Institute  Department of Pediatrics, Hospital block, SBV campus, Pillayarkuppam, Pondicherry
Pondicherry
PONDICHERRY 		 9502234455

rohithareddy459@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Medical College and Research Institute Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 2||Placement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard procedure  This group will have venipuncture done without any device which will take 10 minutes duration. Only verbal reassurance will be given. 
Comparator Agent  Tablet video  A tablet device with a cartoon video will be played during venipuncture procedure for 10 minutes duration. 
Intervention  Virtual Reality Device   A Virtual Reality Device will be used on the child during Venipuncture, which will distract the child and reduce their pain and anxiety levels during the procedure. The device will be used for about 10 minutes duration. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. All children admitted to the Pediatric ward aged 7-12 years in whom venipuncture is planned electively
2. Child should have a Glasgow Coma Scale of 15/15. 
 
ExclusionCriteria 
Details  1. Children with pre-existing photosensitive epilepsy, vertigo, migraine.
2. Children with moderate or severe intellectual disability, and developmental delay.
3. Physical factors preventing placement of the VR headset (e.g: wound on head or face).
4. Child with previous history of syncope/vertigo during adventure games
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the mean differences in child, parent and clinician-reported pain scores as measured by Faces Pain Scale-Revised scale and Visual Analogue scale amongst Immersive Virtual Reality, tablet video, and standard procedure group during venipuncture.  T1 is 10 moinutes prior  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the child reported level of immersion of VR in the Immersive Virtual Reality group using the Gold Rizzo Immersion and Presence (GRIP) inventory.  30 mins  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/10/2025 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  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 - Proposals should be directed to [dr.vikneswari@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 09-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
The main objective of the trial is to know the effects of a virtual reality intervention on pain during venipuncture in children aged 7-12 years, as compared to the tablet video and standard procedure. Children aged 7-12 years admitted to the Pediatric ward will be recruited after informed parental consent and verbal assent. They will be randomly allocated to three groups. In  Immersive VR group, the  child will be wearing a VR game headset during venipuncture procedure during which time, child will be distracted by playing a game during the Venipuncture.  In Tablet video group, child will be watching a cartoon video appropriate for their age during the Venipuncture. In Standard procedure group, child we be given verbal reassurance during venipuncture. In all 3 groups, the child, parent, and clinician reported pain will be assessed using the FACES pain scale at 2 timepoints(before and after venipuncture)
In all the three groups, Heart rate of the child will be monitored during venipuncture. Also, the level of immersion in VR device will be assessed using the GRIP Inventory. The data will be entered and analyzed. 

 
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