Effect of virtual reality headset device on pain fear and anxiety in Pediatric Cancer Patients during Lumbar Punctures LP at a Tertiary Care Centre in Mumbai Open label RCT

Phase I

The feasibility study will be initiated after ethical approval from IEC at TMH  children for intrathecal injection during LP will be allowed to participate in the study subject to written informed consent of parents and assent of the child The exclusion criteria will be strictly applied to finalize the subject  A coded subject ID will be assigned to the children  Demographic and outcome data will be obtained from the medical records of the child. The screening proforma will be completed for children with case record forms before intervention  A general physical examination will be done for all children by the paediatrician and clinical psychologist. The diagnosis will be noted as well as recorded The Pain and  Fear and Anxiety Score outcomes of all eligible participants will be monitored  All data about VR feasibility will be recorded from the case file to the data collection instrument in English The data will be regularly transmitted to the computer in the MS Excel database and stored electronically. All source documents and reports will be stored in the file cabinet. The paediatrician and psychologist will be made aware of the intervention. Recording of Pain and Fear and Anxiety will be carried out by the investigator before taking the child to OT with the help of the Wong Baker Pain Scale and Children Fear Scale and Children Anxiety Meter Scale Data Collection Tools The child will be taken in the OT a left lateral position will be given and a VR headset device will be placed on the child until the completion of intrathecal chemotherapy. The investigator will record the Pain score at 5 and 15 and 30 minutes of the procedure Fear and Anxiety with the help of data collection tools. Data will be collected recorded and sent to a statistician for further analysis and interpretation.