Background: Virtual reality (VR) is an evolving technology that is becoming a common treatment for pain management and psychological phobias. While non-immersive devices (i.e., the Nintendo Wii) have been previously tested with hemodialysis patients, no studies to date have used fully-immersive VR as a tool for intervention delivery. The current pilot trial tests the initial safety, acceptability, and utility of VR during maintenance hemodialysis treatment sessions-particularly, whether VR triggers motion sickness that mimics or negatively impact treatment related symptoms (e.g., nausea). Methods: Hemodialysis patients (n=20) were enrolled in a Phase I single-arm proof-of-concept trial. While undergoing hemodialysis, participants were exposed to our new JovialityTM VR program. This 25-minute program delivers mindfulness training and guided meditation using the Oculus Rift head-mounted display. Participants experienced the program on two separate occasions. Prior and immediately following exposure, participants recorded motion-related symptoms and related discomfort on the Simulator Sickness Questionnaire. Utility measures included end-user's ability to be fully immersed in the virtual space, interact with virtual objects, find hardware user-friendly, and easily navigate the JovialityTM program with the System Usability Score scale. Results: Mean age was 55.3 (+/-13.1) years; 80% male; 60% African American; and mean dialysis vintage was 3.56 (+/-3.75) years. At the first session, there were significant decreases in treatment and/or motion-related symptoms following VR exposure (22.6 vs. 11.2; p=0.03); scores >20 indicate problematic immersion. HD end-users reported high levels of immersion in the VR environment and rated the software easy to operate, with average System Usability Scores of 82.8/100. Conclusions: Hemodialysis patients routinely suffer from fatigue, nausea, lightheadedness, and headaches that often manifest during their dialysis sessions. Our JovialityTM VR program decreased symptom severity without adverse effects. VR programs may be a safe platform to improve the dialysis patient experience.
Background Depression is highly prevalent in individuals on hemodialysis, but it is infrequently identified and remains undertreated. In this paper, we present details of the methodology of a randomized controlled trial (RCT) aimed at testing the feasibility and preliminary efficacy of a 5-week positive psychological intervention in individuals on hemodialysis with comorbid depression delivered using immersive virtual reality (VR) technology. Objective We aim to describe the protocol and design of the Joviality trial whose main objectives are 2-fold: determine the feasibility of the Joviality VR software through metrics capturing rates of recruitment, refusal, retention, noncompliance, and adherence, as well as end-user feedback; and assess preliminary efficacy for outcomes measures of depressive symptoms, psychological well-being and distress, quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalizations. Methods This 2-arm RCT is scheduled to enroll 84 individuals on hemodialysis with comorbid depression from multiple outpatient centers in Chicago, Illinois, United States. Enrollees will be randomized to the following groups: VR-based Joviality positive psychological intervention or sham VR (2D wildlife footage and nature-based settings with inert music presented using a head-mounted display). To be eligible, individuals must be on hemodialysis for at least 3 months, have Beck Depression Inventory-II scores of ≥11 (ie, indicative of mild-to-severe depressive symptoms), be aged ≥21 years, and be fluent in English or Spanish. The Joviality VR software was built using agile design principles and incorporates fully immersive content, digital avatars, and multiplex features of interactability. Targeted skills of the intervention include noticing positive events, positive reappraisal, gratitude, acts of kindness, and mindful or nonjudgmental awareness. The primary outcomes include metrics of feasibility and acceptability, along with preliminary efficacy focused on decreasing symptoms of depression. The secondary and tertiary outcomes include quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalization rates. There are 4 assessment time points: baseline, immediately after the intervention, 3 months after the intervention, and 6 months after the intervention. We hypothesize that depressive symptoms and hemodialysis-related markers of disease will substantially improve in participants randomized to the VR-based Joviality positive psychology treatment arm compared with those in the attention control condition. Results This RCT is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and is scheduled to commence participant recruitment in June 2023. Conclusions This trial will be the first to test custom-built VR software to deliver a positive psychological intervention, chairside, in individuals on hemodialysis to reduce symptoms of depression. Within the context of an RCT using an active control arm, if proven effective, VR technology may become a potent tool to deliver mental health programming in clinical populations during their outpatient treatment sessions. Trial Registration ClinicalTrials.gov NCT05642364; https://clinicaltrials.gov/ct2/show/NCT05642364 International Registered Report Identifier (IRRID) PRR1-10.2196/45100
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