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

Stress Related Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611399
• Other study ID #: MIND-VR/Besta
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: February 5, 2023

Study information

• Verified date: January 2023
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 5, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• COVID-19
• Stress Related Disorder

Intervention

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").

Other:
• Control (CR)
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score at the State-Trait Anxiety Inventory -Y2	A 20 item measure of the level of the state anxiety	Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Primary	Change in score at the Perceived Stress Scale	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
Primary	Change in score at the Depression, Anxiety ans Stress Scale-21 items	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
Primary	Change in score of knowledge on stress and anxiety	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	Change in score at the EQ-5D-5L	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

External Links

•   Johns Hopkins Coronavirus Resource Center. (2020). COVID-19 Map.
•   World Health Organization. (2019). Occupational safety and health in public health emergencies: a manual for protecting health workers and responders.