Comfort, anxiety, and pain significantly impact the quality of life and treatment adherence in cancer patients undergoing chemotherapy. Virtual reality (VR) technology offers a novel non-pharmacological intervention to address these primary concerns. While vital signs provide objective physiological data, they are considered secondary outcomes that may reflect changes in patients' subjective experiences. This study aims to evaluate the effectiveness of smartphone-based virtual reality relaxation (SVR) interventions on improving comfort and reducing anxiety and pain (primary outcomes) in patients with cancer undergoing chemotherapy. Additionally, it assesses the impact on blood pressure and pulse rate (secondary outcomes). This prospective, two-arm, randomized controlled trial involved 99 cancer patients undergoing chemotherapy who were randomized into the SVR group (n = 50) and control group (n = 49) from March to May 2023. The SVR group received a 10-min immersive VR experience featuring 360-degree natural scenery videos with relaxing sounds, while participants in the control group received standard care and guided imagery leaflets. The primary outcomes-comfort, anxiety, and pain-were evaluated at various time points: comfort was assessed at baseline and post-chemotherapy, while anxiety and pain were assessed at four stages (pre-chemotherapy, pre-VR, immediate post-intervention, and post-chemotherapy). Secondary outcomes included vital signs (blood pressure and pulse rate), which were assessed at the same four stages. Cybersickness symptoms were examined post-chemotherapy. Data analysis involved independent t tests, linear regression, and Generalized Estimating Equations (GEE). Among 99 randomized patients, the SVR group reported significantly higher comfort levels (p = 0.01; Cohen's d = 0.4), reduced anxiety (p = 0.01; Cohen's d = 0.50), and pain (p = 0.015; Cohen's d = 0.35) compared to the control group. No significant differences were found in heart rate (p = 0.92), systolic blood pressure (p = 0.36), or diastolic blood pressure (p = 0.95). The majority of participants (66-96%) in the SVR group did not report cybersickness symptoms. SVR shows promise as an intervention for improving comfort and reducing anxiety and pain in cancer patients undergoing chemotherapy. Healthcare providers at chemotherapy centers should consider incorporating VR devices and curated content into patient care routines. ClinicalTrials.gov: NCT05756465, registered on January 22, 2023.
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