The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be: * the length of the laboratory session utilizing virtual reality exposure (feasibility), * the ergonomics and ease of use for both patients and system operators (usability), * the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety). The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.
In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The pilot investigators will be tested for the feasibility, usability and safety of the system in order to obtain information useful in further designs for the clinical trial. The research consists of four laboratory sessions. The first and the last session will be dedicated to participant assessment. During the second and third session the virtual reality scenarios (2 x 10 minutes for each session) will be presented to participants. The participants will be playing a role of someone who is giving a speech (Public speaking scenario) and someone who is speaking on a phone in public (Telephoning in public scenario).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Two VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety. The pilot study will consist of two scenarios: "Public Speaking in Lecture Hall" and "Telephoning in Public". Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes.
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, Poland
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Time frame: At the end of 4th laboratory session within 2 weeks
Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
Number of virtual reality exposure sessions completed in predefined time.
Time frame: At the end of 2nd and 3th laboratory session within 2 weeks
Usability_ 3: immersion, perceived reality and engagement
3 items with 7-point scale, where 1 is "Totally agree" and 7 "Totally disagree": 1. The virtual reality immersed me in all aspects (Immersion), 2. The virtual reality resembled true experiences (Reality), 3. The virtual reality was engaging (Engagement).
Time frame: At the end of 2 and 3 laboratory session within 2 weeks
Safety_1: occurrence and severity of simulator sickness
Simulator sickness is expected adverse effect of the VR. Hence, the Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993) will be administered as a primary outcome measure to evaluate safety of the VR intervention. Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores \>10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as: * mild (no intervention required, all VR sessions completed), * moderate (any intervention needed, e.g. session termination), * severe (hospitalization required), * life-threatening / death. Any unexpected adverse effects will be recorded by a physician and classified as described above.
Time frame: During 2nd and 3th laboratory session within 2 weeks
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