1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
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 - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  NIL


6. For how long will this data be available start date provided 01-06-2025 and end date provided 30-09-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

METHOD:

Patients will be recruited from the outpatient setting of Department of Dentistry (Unit of Pediatric and Preventive Dentistry), University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi. The study will be conducted as a split-mouth study. A total of 100 systemically healthy subjects in the age group of 8-12 years requiring dental treatment in the mandibular arch which involves administration of intraoral injection will be included in the study. After satisfying the inclusion and exclusion criteria, subjects will be randomly assigned to one of the following two groups using computer-generated random table.

Group HBPD: Headset based passive distraction (HBPD) using virtual reality.

Group HBID: Headset based interactive distraction (HBID) using mixed reality. 

Procedure with timing of measurement of primary and secondary objectives:

Anxiety measurement:

Baseline anxiety levels (A) will be measured in all patients in the waiting area before random allocation in any of the two groups at baseline dental examination visit (V0). After dividing patients into either HBPD or HBID groups using a computer generated random table and before the start of any procedure, an operator will record preoperative anxiety levels (A1) using Venham Clinical Anxiety Rating Scale (VCARS). Anxiety will again be measured by the same operator after dental treatment completion and removal of all interventions in both the groups using the Venham Clinical Anxiety Rating Scale (A2).

The pain measurement will be done immediately after administration of intraoral injection. Two scales will be used for measurement of pain: a self-reported scale (Wong Baker FACES Pain Rating Scale) and a non-self-reported scale (Sound, Eye, Motor scale). 

Behaviour assessment:

The behaviour rating scale ‘Venham Behaviour Rating Scale’ for overall behaviour will be used for assessment of behaviour at the end of the treatment procedure. It is a non-self-reported scale with scores ranging from 0-5. The operating dentist will assess the behaviour after each treatment visit. 

Acceptability and feasibility of headset:

Visual Analogue Scale (VAS) will be used for assessment of acceptability and feasibility of headset worn by children, as measured by parents. This will be done after the completion of both dental treatment visits (V2). 

Researcher-based questionnaire (self-designed):

A questionnaire regarding the comfort and acceptability of the Meta Quest 3S headset will be given to the child to answer. The questionnaire will be presented in English or Hindi based on the language that the child prefers.