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OpenTrials
Completed

NCT Number: NCT04611399

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

VR for psychoeducation and relaxation

Behavioral

Use of specifically developed VR contents to deliver psychoeducational content on stress and anxiety (i.e., "MIND-VR") and to train on relaxation techniques (i.e., "The Secret Garden").

Control (CR)

Other

The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.

Primary outcomes

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

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

    A 20 item measure of the level of the state anxiety

  2. Change in score at the Perceived Stress Scale

    Time frame: 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

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

    Time frame: 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

  4. Change in score of knowledge on stress and anxiety

    Time frame: 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

Secondary outcomes

  1. Change in score at the EQ-5D-5L

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

    A measure which defines the state of health and the perceived quality of life

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Collaborators

  • University of Milano Bicocca

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 2, 2020
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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