Efficacy of Immersive Virtual Reality in alleviating pain and distress in cancer patients undergoing pain Interventions: A prospective randomized control trial

After obtaining approval from the Institute Ethics Committee (IEC) and consent, registration will be done in the Clinical Trials Registry of India (CTRI), and patients scheduled for intervention who satisfy the inclusion criteria will be recruited for this study. Patients will be randomized into two groups using a computer-generated random table number.   On the day before the planned intervention, the patient will be admitted to the ward. The baseline distress level as assessed by Distress Inventory for Cancer (DIC-2), baseline NRS score and ESAS-r will be assessed for all patients posted for intervention and palliation. Then, based on the randomization, we shall divide the patients into VR and control groups. VR group – Patients will receive VR along with interventional pain management Control group – Patients will receive pain intervention with sham VR (VR with no video)   VR group: Patients under Group VR will be exposed to VR through the use of a VR head-mounted immersive type of display powered by a smartphone. Relaxation videos developed according to the VR format such as Forest walking, Lake views, Mountain views, will be played according to the patient’s convenience and interest for a period of 15 minutes before the planned procedure, during the entire procedure and 15 minutes following intervention.   Control group: Patients grouped under control group will undergo intervention on the day of the planned procedure. They will receive the sham VR.   After the intervention, the patient’s post procedure NRS score and analgesic requirements at 0, 6, 12, 24 hours, Distress level, ESAS-r and Patient’s satisfaction score will be noted. The patients will be discharged and followed up in the Outpatient Department for 1 week, 2 week and 1 month for the above mentioned parameters.  The data are recorded and will be documented and subjected to statistical analysis. Study design: Randomized control trial Power: 80% Alpha error: 5% (95% significance)    Based on a previous study by Joo Y et al, the mean (SD) VAS score for procedure-related pain is 3.7(1.7).9 Assuming 35% reduction in VAS score as compared to the control group, the mean VAS score is 2.3(1.7). With the power of 80% and absolute precision of 5%, the minimum sample size required is 48 (24 in each group), calculated by using OpenEpi software. After considering a dropout rate of 10%, the corrected sample size was calculated to be 52 (26 in each group). Data will be collected, revised, coded, and entered to the Statistical Package for Social Science (IBM SPSS) version 23. The continuous variables will be represented as mean and standard deviation (SD) or as median and inter-quartile range (IQR) based on the type of distribution. They will be compared using an independent student’s t-test or Mann-Whitney test. The distribution of categorical variables will be expressed in frequency and percentage. The comparison of these categorical variables between the groups will be carried out by using the Chi-square test/ Fisher’s test. The confidence interval is set to 95% and the margin of error accepted is set to 5%. p < 0.05 will be considered as statistically significant. Randomization: Patients will be randomized using computer-generated random table number