Efficacy of smartphone-based virtual reality relaxation in providing comfort to patients with cancer undergoing chemotherapy in oncology outpatient setting in Indonesia: protocol for a randomised controlled trial.

Abstract

Patients with cancer undergoing chemotherapy experience various physical and psychological problems and discomfort. Virtual reality (VR) can be used in technology-based non-pharmacological therapy that can serve as a potential distractor in the symptom management of patients with cancer undergoing chemotherapy. We propose a smartphone-based virtual reality relaxation (S-VR) technique as a complementary modality to provide comfort to patients with cancer, and we will evaluate its effect on patients with cancer undergoing chemotherapy. We will recruit 80 patients from the One Day Chemotherapy 'Tulip' Center of Dr. Sardjito General Hospital, Yogyakarta, Indonesia. This will be a two-arm parallel randomised controlled trial, with a 1:1 allocation and the primary outcome assessor blinded. This study will be divided into two groups: (1) an intervention group, with participants receiving 360° panoramic video content and music relaxation intervention through a VR device (head-mounted display) placed on their head during chemotherapy for ±10 min plus standard care and (2) a control group, with participants receiving guided imagery relaxation therapy in the form of a leaflet plus standard care. We will measure the outcomes after one chemotherapy cycle for each participant. The primary outcome is the effectiveness of the S-VR in improving the comfort of patients. The secondary outcome is the effect of the S-VR on the patients' symptom management self-efficacy, pain, anxiety, blood pressure (systolic blood pressure and diastolic blood pressure) and pulse rate. This study was approved by the Medical and Health Research Ethics Committee of the Faculty of Medicine, Public Health and Nursing of Universitas Gadjah Mada-Dr. Sardjito General Hospital, Yogyakarta, Institutional Review Board (approval number: KE/FK/0301/EC/2023). Written informed consent will be obtained from all participants who enrol in the study. Dissemination will be conducted through peer-reviewed publications and conference presentations. NCT05756465.