Pilot and Feasibility Studies (Oct 2022)
The influence of a virtual reality entertainment program on depressive symptoms and sedentary behaviour in inpatient stroke survivors: a research protocol for a pilot randomized controlled trial
Abstract
Abstract Background Sedentary behaviour among stroke inpatients may be due to high rates of depressive symptoms after stroke. Thus, efforts to address depressive symptoms among stroke inpatients are warranted to in turn lessen sedentary behaviour. Despite evidence that virtual reality (VR) is emerging as a method to help with depression, the use of VR to improve depression among inpatient stroke survivors has yet to be studied. In this paper, we report on the protocol investigating the feasibility of a VR entertainment system at improving depressive symptoms among stroke survivors receiving inpatient rehabilitation. Methods In this single-blind randomized controlled trial, 30 inpatient stroke survivors from the rehabilitation unit at Kelowna General Hospital will be randomized to either (1) intervention: 3 times per week of VR entertainment for duration of inpatient rehabilitation or (2) control: usual care. Individuals will be included if they have a confirmed diagnosis of stroke, are 19 years of age or older, able to provide informed consent, have physician clearance to participate in the study (medically stable or fit), or are able to understand English. Outcome measures to address depressive symptoms (primary outcome), sedentary behaviour, motivation, anxiety, stress, and happiness (secondary outcome) will be administered at two timepoints: (1) baseline (T1) and (2) post-intervention (T2). Study analyses will consider study feasibility indicators and clinical (statistical) outcomes. Means and standard deviations (for continuous variables) and frequencies and proportions (for categorical variables) will be used to summarize the variables. Feasibility indicators will be dichotomized into either ‘success’ if they meet the a priori criteria, or ‘revise’ if they do not meet the criteria. Intervention effects post-intervention (T2) for the primary and secondary clinical outcomes will be estimated using linear regression including baseline (T1) controlling for age and sex. Discussion The results of this trial will add to our understanding of depression and sedentary behaviour among individuals receiving inpatient stroke rehabilitation as well as the feasibility of a VR entertainment program to improve depressive symptoms, which will in turn may lessen sedentary behaviour in inpatient stroke survivors. Trial registration ClinicalTrials.gov Identifier: NCT04011202 . First posted July 8, 2019 (study postponed from March 2020 to July 2021 due to COVID-19).
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