Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-50 y.o.
- •Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
- •Signing informed consent
排除标准
- •Occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
- •Occurrence and/or recognition:
- •bipolar disorder,
- •mental retardation
- •Exclusion based on interview:
- •drug addiction,
- •alcohol addiction,
- •participating in the experimental session while intoxicated
- •(current) neurological treatment of chronic disease of central nervous system,
- •paroxysmal vertigo,
- •presence of suicidal thoughts , tendencies or attempts,
- •participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
研究组 & 干预措施
VR Mind
Two VR Mind sessions using experimental virtual reality scenarios. During these two sessions, participants will be exposed to virtual reality environment, for 2 x 10 min each session.
干预措施: VR Mind (Behavioral)
结局指标
主要结局
Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks.
时间窗: At the end of 4th laboratory session within 2 weeks
Number of participants, who have completed 4 laboratory sessions within 2 weeks.
Feasibility_2: Number of virtual reality exposure sessions completed in predefined time.
时间窗: At the end of 2nd and 3th laboratory session within 2 weeks
Number of virtual reality exposure sessions completed in predefined time.
Usability_ 3: immersion, perceived reality and engagement
时间窗: At the end of 2 and 3 laboratory session within 2 weeks
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).
Safety_1: occurrence and severity of simulator sickness
时间窗: During 2nd and 3th laboratory session within 2 weeks
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.
次要结局
未报告次要终点