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临床试验/NCT02986555
NCT02986555Unknown不适用

Virtual Reality Stress and Relief Project, Research on Quantification of VR Related Stress, Motion Sickness and Visual Fatigue

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Change of Heart rate variability especially ratio of High Frequency and Low Frequency

研究概览

简要总结

Current virtual reality device makes motion sickness and visual fatigue having limitation for recreation and other clinical approaches. Still there is no standardized quantification of motion sickness and visual fatigue measurement with objective approach. Current biofeedback accompanied with virtual reality would be promising tool for stress relief.

详细描述

Current virtual reality device makes motion sickness and visual fatigue having limitation for recreation and other clinical approaches. Still there is no standardized quantification of motion sickness and visual fatigue measurement with objective approach. After quantification and improvement with these shortcomings, current biofeedback accompanied with virtual reality would be promising tool for stress relief. This research aims to measure objective motion sickness and visual fatigue with psychological stress in highly stressed group, and to compare between stress relief with existing biofeedback only approach and relief with mixed biofeedback and virtual reality relaxation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scored at least 20 on the PSS-10 (Perceived Stress Scale 10) to verify highly psychological stressed participants at the baseline visits.

排除标准

  • the existence of a current Major depressive disorder or panic disorder, psychotic disorder (e.g., schizophrenia or delusional disorder), bipolar affective disorder,active alcohol or drug use disorder, neurological illness including significant cognitive impairment or Parkinson's disease, mental retardation, significant medical conditions, epilepsy, histories of alcohol or drug dependence, personality disorders, or brain damages during the screening and baseline visits, per the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • the existence of active disease in both orbital parts

结局指标

主要结局

Change of Heart rate variability especially ratio of High Frequency and Low Frequency

时间窗: Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)

次要结局

  • Change of Respiration Rate(Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation))
  • Visual analogue scale for motion sickness(Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation))
  • Visual analogue scale for negative emotion(Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation))
  • Visual analogue scale for visual fatigue(Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation))
  • Psychological distress scale with Perceived Stress Scale 10(Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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