The Effect of Smartphone-Based Virtual Reality Relaxation (S-VR) On the Comfort on Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

This study presents Smartphone-Based Virtual Reality Relaxation (S-VR) as a complementary modality in cancer treatment. We will conduct a randomised controlled trial to evaluate its impact in cancer patient undergoing chemotherapy.

This study is a two-arm parallel randomised controlled trial with a 1:1 allocation. This study divided two groups, namely the intervention group in the form of SVR therapy with the installation of a VR device (head-mounted display/HMD) on the respondent's head during chemotherapy. The control group received standard care through leaflets containing instructions for relaxation techniques with image visualization as guided imagery therapy. The group's determination, apart from randomization, will also use envelope concealment and outcome assessor will be blinded during data collection. The protocol is composed according to Standard Protocol Items: Recommendations for Interventional Trials and its checklist.

The sample size calculation used the G*Power for windows application Version 3.1.9.6. The effect size is 0.81, type 1 error (α) = 5% (two-tailed), power (1-β) 90%, and the allocation ratio between groups is 1:1. Effect size refers to previous studies with similar outcomes. Based on the G Power calculation, the calculation of study sample size is 34 people per group. We will drop out by 15%, thereby increasing the sample size to 40 subjects per group.

The sampling technique will use consecutive sampling. This non-probability sampling method involves recruiting everyone from the accessible population during a given time interval or for a specific sample size. Cancer patients who have scheduled chemotherapy and meet the requirements in the data collection time will be offered to be involved in the study.

Researchers will carry out the screening process to determine eligible patients as study participants. The patient's medical record will also be validated to fulfill the baseline information (e.g. anthropometric data, laboratory, patient identification, and laboratory result). Allocation sequence generation will be through simple randomization of study participant using a formulation from the Microsoft Excel program (randbetween formula) and allocation sequence concealment will use sealed envelope. Participants in the intervention and control groups will be treated with concealment from received envelopes containing random numbers from the randomization procedure. Outcome assessor (Nurse who appointed by researcher to be responsible for collection of outcome data) and data analysts will be blinded from participant allocation. This blinding is carried out, due to the technical nature of VR interventions, making it difficult to blind study participant during the intervention, thus to minimize the potential for methodological bias, the study must blind the outcome assessor or data analysts.