Piloting a Virtual Reality-Based, Randomized Controlled Trial of Psychosocial Responses to Neighborhood Physical Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in heart rate variability
研究概览
简要总结
This clinical trial compares virtual reality viewing of an unaltered streetscape versus a digitally manipulated opposite streetscape to assess the psychosocial response in participants. Visible measures of neighborhood factors might be associated with health outcomes and risk factors of those outcomes. Short-term exposure to virtual reality environments representing very high or very low levels of neighborhood physical disorder - presence or absence of garbage/litter, presence or absence of graffiti, presence or absence of an abandoned building, presence or absence of large dumpsters, poor or very well-kept building conditions, poor or very well-kept yard conditions, poor or very well-kept road verge conditions may be a safe and effective way to assess psychosocial response in participants.
详细描述
PRIMARY OBJECTIVES:
I. Compare sympathetic autonomic measures (heart rate variability and skin conductance) between participants viewing, in virtual reality, their streetscape as a digitally manipulated opposite version with respect to physical disorder indicators versus participants viewing their streetscape as a digital twin with respect to physical disorder indicators.
II. Compare self-report measures (Self-Assessment Manikin and state anxiety ratings) between participants viewing, in virtual reality, their streetscape as a digitally manipulated opposite version with respect to physical disorder indicators versus participants viewing their streetscape as a digital twin with respect to physical disorder indicators.
III. Record side effects of interacting within a virtual reality environment over short periods of time (3-5 min):
IIIa. Quantify frequency of side effects; IIIb. Explore whether side effects increase across subsequent VR sessions of the cross-over study; IIIc. Explore whether side effects vary by VR intervention arm (digital twin of own streetscape or digitally manipulated opposite indicators of physical disorder of own streetscape).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18+
- •Must currently live (4+ night/week) at the residence being studied. Only one resident per household will be selected
- •Must understand and be able to read English
- •Must agree to have residence photographed
- •Must be able to wear a VR head mounted display
- •Must live in neighborhood that has been selected for study
- •Must be willing and able to attend an approximately 2 hour in-person visit on Ohio State University (OSU) campus
排除标准
- •Pregnant women
- •Visual or mobility impairment
- •Cannot have epilepsy or other condition that would inhibit them from being able to use a VR headset
研究组 & 干预措施
Arm II (opposite followed by twin streetscape)
Participants have their streetscape photographed. Participants view a standard residential streetscape using VR for up to 5 minutes. Patients then view their streetscape with the opposite physical disorder using VR for up to 5 minutes followed by viewing a digital twin of their streetscape with identical physical disorder using VR for up to 5 minutes.
干预措施: Survey Administration (Other)
Arm I (twin followed by opposite streetscape)
Participants have their streetscape photographed. Participants view a standard residential streetscape using VR for up to 5 minutes. Patients then view a digital twin of their streetscape with identical physical disorder using VR for up to 5 minutes followed by viewing their streetscape with the opposite physical disorder using VR for up to 5 minutes.
干预措施: Survey Administration (Other)
Arm I (twin followed by opposite streetscape)
Participants have their streetscape photographed. Participants view a standard residential streetscape using VR for up to 5 minutes. Patients then view a digital twin of their streetscape with identical physical disorder using VR for up to 5 minutes followed by viewing their streetscape with the opposite physical disorder using VR for up to 5 minutes.
干预措施: Virtual Technology Intervention (Other)
Arm II (opposite followed by twin streetscape)
Participants have their streetscape photographed. Participants view a standard residential streetscape using VR for up to 5 minutes. Patients then view their streetscape with the opposite physical disorder using VR for up to 5 minutes followed by viewing a digital twin of their streetscape with identical physical disorder using VR for up to 5 minutes.
干预措施: Virtual Technology Intervention (Other)
结局指标
主要结局
Change in heart rate variability
时间窗: From baseline to completion of virtual reality (VR) viewings, up to 1 day
Mean heart rate variability over the entire session of each VR condition will be calculated from electrocardiograph data. Will compare the difference between two VR conditions (viewing opposite neighborhood image versus viewing twin neighborhood image) using a crossover design. Analyses of outcomes will be conducted using generalized linear mixed model approaches.
Change in skin conductance
时间窗: From baseline to completion of VR viewings, up to 1 day
Skin conductance, measured as microsiemens, will be calculated as the mean value over each VR condition. Will compare the difference between two VR conditions (viewing opposite neighborhood image versus viewing twin neighborhood image) using a crossover design. Analyses of outcomes will be conducted using generalized linear mixed model approaches.
Affective reaction
时间窗: After completion of VR viewings, up to 1 day
Assessed via Self-assessment Manikin. Will compare the difference between two VR conditions (viewing opposite neighborhood image versus viewing twin neighborhood image) using a crossover design. Analyses of outcomes will be conducted using generalized linear mixed model approaches.
Anxiety
时间窗: After completion of VR viewings, up to 1 day
Assessed via Spielberger State-Trait Anxiety Inventory short form. Will compare the difference between two VR conditions (viewing opposite neighborhood image versus viewing twin neighborhood image) using a crossover design. Analyses of outcomes will be conducted using generalized linear mixed model approaches.
Participant reported discomfort
时间窗: After completion of VR viewings, up to 1 day
This is an open-ended outcome measure. Discomfort reported by participants will be recorded by study staff.
次要结局
未报告次要终点
研究者
Jesse Plascak
Principal Investigator
Ohio State University Comprehensive Cancer Center