A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Flight Anxiety Situations Questionnaire(FAS)
研究概览
简要总结
The goal of this clinical trial is to explore the efficacy of VR exposure intervention in alleviating fear of flying through a randomized controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The flight anxiety situations questionnaire (FAS) score is no less than 56 points (the critical value is set as two or more standard deviations higher than the average of the normal population);
- •Aged between 18 and 65 years old;
- •Have normal intelligence and good or corrected vision;
- •No family history of any mental illness or other mental disorders other than anxiety disorder;
- •Currently not receiving any treatment for phobia, including but not limited to taking psychotropic drugs (unless the dose is stable for more than 3 months, and the subject agrees to continue taking the dose throughout the study);
- •Have at least 1 flight experience;
排除标准
- •The participant cannot tolerate or adapt to VR stimulation;
- •The participant was unable to immerse themselves well in the VR environment;
- •Severe physical diseases and physical diseases induced by stimulation, including cardiovascular and respiratory diseases, etc.;
- •Have a history of neurological diseases (such as epilepsy, cerebrovascular accident, etc.) or brain trauma or brain surgery;
- •The subject suffers from a physical disease and is not in a stable treatment period (such as hyperthyroidism, visual impairment, etc.), resulting in the inability to fully participate in the experimental process;
- •Pregnant women.
结局指标
主要结局
Flight Anxiety Situations Questionnaire(FAS)
时间窗: from baseline to 4 weeks
It was compiled by Van Gerwen et al. in 1999 to assess flight-related anxiety in different situations. It consists of 32 items rated on a 5-point scale from 1 ("Not at all anxious") to 5 ("Extremely anxious"). "), with a total score of 32-160 points. The scale consists of three subscales that assess anticipatory flight anxiety (anxiety that occurs when a person anticipates flying), in-flight anxiety, and generalized flight anxiety, with item numbers of 14, 11, and 7 respectively. This questionnaire has good reliability and validity, has established norms, can be used as a clinical measurement tool for fear of flying, is widely used in clinical practice and research, and is used as the main efficacy indicator.
次要结局
- The Beck Anxiety Inventory(BAI)(from baseline to 4 weeks)
- State-Trait Anxiety Inventory(STAI)(STAI-t is assessed only once at baseline. STAI-s is assessed from baseline to 4 weeks.)
- Subjective Units of Distress(SUDs)(assessed every one minute during intervention, up to 24 hours)
- Igroup Presence Questionnaire(IPQ)(The IPQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2))
- Physiological indicators(from baseline to 2 weeks)
- Flight Anxiety Modality Questionnaire(FAM)(from baseline to 4 weeks)
- Stimulator Sickness Questionnaire(SSQ)(The SSQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2))
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center