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

June 1, 2023 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality (VR) Group
The treatment for the participants allocated to the VR Group consists of three home-sessions of approximately 30 minutes each, conducted over one week. In each session, participants will be asked to try for about 15 minutes "MIND-VR". Subsequently, they will try the virtual relaxation content "The Secret Garden".
Behavioral: VR for psychoeducation and relaxation
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").
Active Comparator: Control (CR) Group
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
Other: Control (CR)
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
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
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
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
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
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
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University of Milano Bicocca

Investigators

  • Study Director: Federica Pallavicini, PhD, University of Milano Bicocca
  • Principal Investigator: Eleonora F Orena, PhD, Foundation IRCCS Neurological Institute Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

February 5, 2023

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIND-VR/Besta

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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