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 - 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 - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sudhanishneela19@gmail.com].
   


6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
   Response - Immediately following publication. No end date.
   


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

A randomised controlled study is designed to assess the efficacy of virtual reality-assisted

health education in smoking cessation among smokers visiting tertiary care centres. The tobacco users

of age 18 years to 64 years attending Tobacco Cessation Clinic at Department of Public Health

Dentistry, Tamil Nadu Government Dental College and Hospital satisfying the eligibility criteria are

recruited for the present study. Physically and mentally challenged individuals, subjects currently

using NRT or anti-depressants, those diagnosed with oral cancer, subjects diagnosed with epileptic

conditions and those diagnosed with cardiac conditions are excluded from the study.

A simple random sampling technique is employed to select the desired sample of participants.

The study participants are clearly informed about the purpose of the study by providing patient

information sheet. Written informed consent is obtained from the study participants. Then, the

participants are randomly allocated into study and control groups using a computer-generated random

sequence.

The study group will receive VR-based tobacco cessation interventions along with routine

health education. The control group participants will receive the routine audio-visual assisted health

education for smoking cessation. Both the group participants will receive interventions for a duration

of 15 – 30 minutes in each session. A quit date would be fixed for both study and control group leaving

14 days from the first visit as grace time for reducing tobacco use. The participants are followed up

from the quit date for 1, 3 and 6 months to evaluate the fagerstorm addiction scores, self-reported

continuous tobacco abstinence and point prevalence tobacco abstinence and relapse rates.