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临床试验/NCT04611399
NCT04611399已完成不适用

MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change in score at the State-Trait Anxiety Inventory -Y2

研究概览

简要总结

Since the COVID-19 pandemic began, several psychological support programs for health care workers have been implemented, especially group or individual counseling sessions delivered face-to-face or using phones and video conferencing platforms. However, there are significant barriers to the delivery of such psychological initiatives. In this context, digital interventions to improve health services and care outcomes are recommended for implementing and providing remote psychological support. Virtual reality can play a relevant role in providing psychological care to healthcare workers facing COVID-19. New commercial head-mounted display have made virtual reality accessible even to the mass audience, breaking down the barriers in the diffusion and use of this technology. Thanks to this fact, virtual reality can now be autonomously used by people and offered to provide psychological assistance remotely. Within this context, this randomized controlled study aims to investigate the efficacy of a virtual reality home-based program for diminishing stress and anxiety in a sample of Italian healthcare workers involved in the COVID-19 pandemic.

详细描述

Since the COVID-19 pandemic began, several psychological support programs for health care workers have been implemented, especially group or individual counseling sessions delivered face-to-face or using phones and video conferencing platforms. However, there are significant barriers to the delivery of such psychological initiatives. In this context, digital interventions to improve health services and care outcomes are recommended for implementing and providing remote psychological support.

Virtual reality can play a relevant role in providing psychological care to healthcare workers facing COVID-19. New commercial head-mounted display have made virtual reality accessible even to the mass audience, breaking down the barriers in the diffusion and use of this technology. Thanks to this fact, virtual reality can now be autonomously used by people and offered to provide psychological assistance remotely.

Within this context, this randomized controlled trial (RCT) aims to investigate the efficacy of a virtual reality home-based program for diminishing stress and anxiety in a sample of Italian healthcare workers involved in the COVID-19 pandemic. In particular, the objective is to compare the efficacy of this type of training with respect to the same program without virtual reality and a waiting list.

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
None

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

入选标准

  • Age > 18, < 65;
  • Having worked on the front line as a doctor or nurse during the COVID-19 emergency (i.e., having assisted COVID-19 patients or having worked in departments dedicated to COVID-19 patients);
  • Normal or corrected to normal visual acuity;
  • Normal or corrected to normal hearing ability.

排除标准

  • Physical illness: cardiovascular issues, neurological illness, epilepsy;
  • Pharmacotherapy with: psychotropic drugs, anti-hypertensive drugs, anti-epileptics;

结局指标

主要结局

Change in score at the State-Trait Anxiety Inventory -Y2

时间窗: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up

A 20 item measure of the level of the state anxiety

Change in score at the Depression, Anxiety ans Stress Scale-21 items

时间窗: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up

A 21 item in 3 self-report scales which measures depression, anxiety and stress

Change in score at the Perceived Stress Scale

时间窗: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up

A 10 item measure of the level of stress perceived in the last month

Change in score of knowledge on stress and anxiety

时间窗: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up

A 7 item measure at the ad hoc questionnaire to assess the knowledge of stress and anxiety

次要结局

  • Change in score at the EQ-5D-5L(Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Sponsor

研究点 (2)

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