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临床试验/NCT07415239
NCT07415239已完成不适用

Validity for Stress Reduction of Virtual Reality Based Mental Health Care Service System

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
change in level of salivary cortisol

研究概览

简要总结

The purpose of this study is to verify the effect of virtual reality (VR) intervention on stress reduction for workers. After inducing stress by the Socially Evaluated Cold Pressure Test (SECPT), Investigators should explore recovery of stress response in VR intervention and control condition. Healthy individuals were randomly assigned to one of VR intervention group and control group.

详细描述

Investigators will assess whether subjective stress ratings and saliva cortisol elevations to the SECPT can be decreased by VR intervention more rapidly compared to control condition. After screening, pre-evaluation is conducted on healthy individuals who agreed to participate in the study. Experimental sessions run in the afternoon (between 14:00 and 17:00) in the virtual reality laboratory to control for diurnal cycle of cortisol. After arrival at the laboratory, participants were randomly assigned to one of two experimental conditions (VR intervention or control). At this point, psychological distress was recorded and baseline saliva sample was collected. After the first assessment, participants immersed their hand in ice water during 3 minutes and were watched by an unfamiliar person and videotaped during hand immersion. Immediately after participants took the SECPT, they rated on the Visual Analogue Scale (VAS) how stressful the previous situation had been and the second saliva sample was collected (the 2nd measurement). Thereafter, participants of VR intervention group go through VR intervention in a virtual seaside environment with congruent sounds, whereas those of control group are allowed to read materials of stress. Participants will be asked to collect their saliva and fill a VAS immeiately after the recovery period (the 3rd measurement) and 30 minutes after cessation of the stress manipulation (the 4th measurement). THe VR intervention is expected to cause more rapid recovery of stress responses than a control intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • workers over the age of 19 and under 65
  • healthy individuals without pathological problems of corisol levels such as Cushing's syndrome
  • being able to understand the protocol and voluntarliy agree to participate the study

排除标准

  • age under 19 or over 65
  • suffering from metabolic syndrome
  • having psychosis usch as schizophrenia or bipolar disorder or a history of them

研究组 & 干预措施

experimental

Experimental

干预措施: virtual reality intervention (Behavioral)

active comparator

Active Comparator

干预措施: control intervention (Behavioral)

结局指标

主要结局

change in level of salivary cortisol

时间窗: baseline, at the end of stress manipulation (3 minutes after the initiation of stress manipulation), immediately after intervention (5 minutes of intervention), 30 minutes after the end of stress manipulation

Saliva cortisol will be collected in sampling tubes with cotton swabs (Salivette®; Sarstedt, Leicester, UK) after Baseline, stress manipulation, intervention, and 30 minutes after stress provoking, for a total of four samples. The saliva cortisol is assessed with a competitive enzyme immunoassy (EIA) designed for quantitative in vitro measurement of cortisol in saliva (Spectria Cortisol Coated Tube RIA, Orion Diagnostica, Espoo, Finland) following the manufacturer's protocol.

change in subjectie stress ratings

时间窗: baseline, at the end of stress manipulation (3 minutes after the initiation of stress manipulation), immediately after intervention (5 minutes of intervention), 30 minutes after the end of stress manipulation

Participants will be rated on the Visual Analogue Scale (VAS) how stressful they are at baseline, after stress manipulation, after recovery intervention, 30 minutes after stress manipulation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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