Contemporary Clinical Trials Communications (Aug 2022)

Immersive virtual reality in a northern Queensland haemodialysis unit: Study protocol for a cross-over randomized controlled feasibility trial (ACTRN12621000732886)

  • Wendy Smyth,
  • Joleen McArdle,
  • John Body-Dempsey,
  • Valli Manickam,
  • Anne Swinbourne,
  • Ickjai Lee,
  • Jason Holdsworth,
  • Olumuyiwa Omonaiye,
  • Cate Nagle

Journal volume & issue
Vol. 28
p. 100956

Abstract

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Introduction: Despite being a life-preserving medical treatment, the demands of haemodialysis are a significant impost on individuals, posing considerable burdens on their work, vocational activities and involvement with family and community. In our region, patients who have had to relocate considerable distances to a regional city for dialysis, and First Nations people, are less likely to attend all scheduled dialysis sessions. Virtual reality (VR) has been shown to improve engagement with care of people on haemodialysis.This manuscript describes the protocol for a cross-over randomised controlled trial (RCT) that will explore the impact of an immersive VR experience for patients attending a northern Queensland, Australia, haemodialysis service. Methods: The design is a crossover RCT, with 8 clusters according to haemodialysis location and schedule. Clusters (5 participants in each) will be randomized by computer program. Participants in the trial will be patients who undergo haemodialysis three times/week at one of two dialysis units. During the 4-week intervention period (12 haemodialysis sessions), participants will be provided a headset with vision representative of the natural environment, and with audio. The 4-week control period will comprise usual activities, such as watching television, reading and sleeping. Outcomes will be measured by participants': attendance at scheduled dialysis sessions; adherence to lifestyle modifications; wellbeing, anxiety and depression; acceptability and usability of VR; and adverse events such as nausea. The feasibility and acceptability of the intervention from clinicians’ perspectives will also be explored. Discussion: If this VR intervention is feasible, then participants may engage more with haemodialysis regimens and self-care in this very clinical environment. Trial registration: ACTRN12621000732886.