An interventional study of Virtual Reality with Beat Saber in Musculoskeletal Diseases, Mental Health Disorder and Back Pain, Low, sponsored by Molde University College. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Molde University College · Not applicable, Interventional, and Health services research
Work-related attention bias modification training and virtual reality training in occupational rehabilitation is a multisite pilot study.
The quantitative aim of this pilot study is to compared virtual reality (VR) training and attention bias modication (ABM) training to investigate whether the different training forms result in different results measured with work-related outcomes and cognitive outcomes. The qualitative aim of this pilot study is to investigate the patients' experiences with the usage of VR.
Three rehabilitation insitutions will be recruiting patients participating in occupational rehabilitation, and the study will compare the outcomes of work-related interventions with and without the addition of ABM or VR training.
The study seeks to determine if these interventions can improve work ability, reduce symptoms of depression and anxiety, and change attentional bias from negative to positive stimuli.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Molde University College is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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The objective of this study is to investigate whether VR and ABM training increases work ability, work-related self-efficacy, attention and reduces symptoms of depression and anxiety and consequently change an attentional bias from negative to positive stimuli. We will compare patients receiving work-related interventions + VR, work-related interventions + ABM training and work-related interventions only. We will also investigate whether positive changes in attentional bias are associated with increased work participation. Self-reported work ability, self-efficacy, depression, anxiety and objective computerised cognitive and emotional testing will be assessed at baseline (start rehabilitation/treatment) and at posttest (end rehabilitation/treatment).
Device: Virtual Reality with Beat Saber
The objective of this part is to investigate the experiences in using VR. R\&D personell will make individual interviews with five patients at each of the three clinics involved in piloting VR. The aim of the interviews will be to capture how the patients experienced the VR activity, the demands of the VR activity, how VR has influenced different aspects of health and whether VR has influenced the abilities to return to work.
The VR activity used in the intervention was an add-on activity that did not replace any other activities in the programme. The off-the-shelf product Beat Saber (Beat Games, Prague, The Czech Republic) is the VR game of choice in our study. In collaboration with the participating clinics a systematic VR activity plan will be developed. This includes the selection of games and designing a plan that is interesting and motivating both for patients and clinicians.
Increase work ability
Self-reported questionnaire measures, (Work Ability Scale). Work ability: Self-rated work ability was assessed using a single-item question to determine the WAS; this question was published by Gould et al. as part of the full work ability index (WAI). The question used by this study to measure WAS ("current work ability compared with your lifetime best") used a scale of 0 to 10 (0 = "completely unable to work" and 10 = "work ability at its best"). The following measurement classification from Gould et al. \[46\] was used: poor (0 to 5), moderate (6 to 7), good (8 to 9) and excellent (10).
Time frame: Baseline and discharge (four weeks), and 6 and 12 months after discharge
Reduced depression and anxiety
Self-reported questionnaire measure, (The Hospital Anxiety And Depression Scale).
Time frame: Baseline and discharge (four weeks)
Increase expectations to return to work
Self-reported questionnaire measures, (Return-to-Work Expectation)
Time frame: Baseline and discharge (four weeks), and 6 and 12 months after discharge
Increased cognitive performance and attention
Computerized cognitive measures. - Rapid Visual Information Processing (Cambridge Cognition, 2020). The mean response latency on trials where the subject responded correctly. Calculated across all assessed trials.
Time frame: Baseline and discharge (four weeks)
Increased cognitive performance and memory
Computerized cognitive measures. - Spatial Working Memory (Cambridge Cognition, 2020). The number of times the subject incorrectly revisits a box in which a token has previously been found.
Time frame: Baseline and discharge (four weeks)
Increased cognitive performance
Computerized cognitive measures. - Stop Signal Task (Cambridge Cognition, 2020). The estimate of time when an individual can successfully inhibit their responses 50% of the time.
Time frame: Baseline and discharge (four weeks)
Patients's experiences in using VR
Interview guide based on the participants experience.
Time frame: From discharge up to 5 month after discharge.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jan 2022 (actual). Primary completion is estimated for Jan 2026, 48 months after the start.
Of 251 non-industry interventional studies with no phase under Musculoskeletal Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 48 months is above that.
Counting every sponsor, half of 266 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
Musculoskeletal Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Molde University College