VRCT - Randomized Controlled Trial
First Manuscript Published Oct 31, 2020 in BMC: Pilot and Feasibility Studies
"Introducing virtual reality therapy for inpatients with dementia admitted to an acute care hospital: learnings from a pilot to pave the way to a randomized controlled trial"
ClinicalTrials.gov ID number: NCT03941119
Behavioural and Psychological Symptoms of Dementia (BPSD) are particularly difficult to manage in acute care settings, and often result in the use of pharmacological interventions and/or physical restraints which are associated with negative health outcomes. Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to manage some of these symptoms, but can be difficult to achieve in frail older adults with cognitive, sensory, and mobility impairments. Virtual Reality (VR) is a novel technology that uses special Head Mounted Display (HMD) to generate simulated immersive experiences that can make one feel as being truly present in another place (i.e. outside in a calming natural environment). As VR technologies become increasingly accessible and affordable, there is an opportunity to introduce this technology into acute care settings, however, to date there have been no systematic evaluations of the feasibility of using VR HMDs on hospitalized individuals with Dementia.
The primary objectives is to investigate the clinical outcomes, the optimal VR characteristics, and the potential impact on BPSD for patients with dementia admitted to acute care hospital. Secondary objective is to establish a framework for introducing non-pharmacological therapies in acute care hospitals.
This will be an open randomized-controlled trial conducted over a 15-month period at MGH with a target total recruitment of 200 participants (the treatment arm plus the control arm). During their hospital stay, recruited patients will participate in one or more sessions of immersive VR-experience (VR-therapy sessions) for up to 20 minutes, every 24-72h of their stay. The mixed-methods design includes collection of quantitative physiological markers (blood pressure, HR, BG), qualitative observations, QoL questionnaire scores, and pre/post VR-session semi-structured interviews. Demographics, diagnoses, use of sedative medication, and factors related to participants’ hospital care experience will be collected by the research team from the hospital’s electronic patient medical records. Episodes of vertigo, dizziness, nausea, agitation, hallucinations, delusions, paranoia, neck pain, headaches, occurring during the hospital stay will be collected and recorded by the research team.
If successful, VRx could become standard of care for individuals with cognitive and physical impairment, representing a less costly, safer, and more ethically acceptable therapy that can reduce the need for sedatives and antidepressants, and improve patient and caregiver quality of life.