Trials Volume 9
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Study protocolThe potential of virtual reality as anxiety management tool: a randomized controlled study in a sample of patients affected by generalized anxiety disorderAlessandra Gorini and Giuseppe Riva  Trials 2008,
9:25doi:10.1186/1745-6215-9-25 Abstract (provisional)
Background
Generalized anxiety disorder (GAD) is a psychiatric disorder characterized by a constant and unspecific anxiety that interferes with daily-life activities. Its high prevalence in general population and the severe limitations it causes, point out the necessity to find new efficient strategies to treat it. Together with the cognitive-behavioural treatments, relaxation represents a useful approach for the treatment of GAD, but it has the limitation that it is hard to be learned. To overcome this point we propose the use of virtual reality (VR) to facilitate the relaxation process by visually presenting key relaxing images to the subjects. We argue that the visual presentation of a virtual calm scenario can facilitate patients' practice and mastery of relaxation, making the experience more vivid and real than the one that most subjects can create using their own imagination and memory.
According to these premises, the aim of the present study is to investigate the advantages of using a VR-based relaxation protocol in reducing anxiety in patients affected by GAD.
Methods
The trial is based on a randomized controlled study, including three groups of 25 patients each (for a total of 75 patients): (1) the VR group, (2) the non-VR group and (3) the waiting list (WL) group. Patients in the VR group will be taught to relax using a VR relaxing environment and audio-visual mobile narratives; patients in the non-VR group will be taught to relax using the same relaxing narratives proposed to the VR group, but without the VR support, and patients in the WL group will not receive any kind of relaxation training. Psychometric and psychophysiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as qualitative dependent variables.
Conclusion
We argue that the use of VR for relaxation represents a promising approach in the treatment of GAD since it enhances the quality of the relaxing experience through the elicitation of the sense of presence. This controlled trial will evaluate the effects of the use of VR in relaxation while preserving the benefits of randomization to reduce bias.
Trial Registration: NCT00602212 (ClinicalTrials.gov)
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
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