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

NCT04611399 | Completed

• 1 other identifier: MIND-VR/Besta
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Related Disorder

Keywords

virtual reality; stress; anxiety; prevention; treatment; relaxation techniques; psychoeducation; COVID-19; healthcare workers

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in score at the EQ-5D-5L

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

Study Arms (2)

Virtual Reality (VR) Group

EXPERIMENTAL

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

Control (CR) Group

ACTIVE COMPARATOR

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

Other: Control (CR)

Interventions

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").

Virtual Reality (VR) Group

Control (CR) OTHER

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

Control (CR) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• University of Milano Bicocca: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

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  PMID: 40053782 DERIVED

• Pallavicini F, Orena E, di Santo S, Greci L, Caragnano C, Ranieri P, Vuolato C, Pepe A, Veronese G, Stefanini S, Achille F, Dakanalis A, Bernardelli L, Sforza F, Rossini A, Caltagirone C, Fascendini S, Clerici M, Riva G, Mantovani F. A virtual reality home-based training for the management of stress and anxiety among healthcare workers during the COVID-19 pandemic: study protocol for a randomized controlled trial. Trials. 2022 Jun 2;23(1):451. doi: 10.1186/s13063-022-06337-2.

  PMID: 35655231 DERIVED

Related 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.

MeSH Terms

Conditions

Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Federica Pallavicini, PhD

  University of Milano Bicocca

  STUDY DIRECTOR

• Eleonora F Orena, PhD

  Foundation IRCCS Neurological Institute Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study can be defined as a controlled and randomized clinical trial, single-blind and monocentric, aimed at studying the efficacy of the intervention with virtual reality contents in reducing stress and anxiety in healthcare personnel involved in the care of COVID-19 patients. The study will be conducted according to the indications of Good Clinical Practices. The clinical efficacy of the intervention will be assessed at two different time distances (T0, T1).

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 2, 2020
• Study Start: March 5, 2021
• Primary Completion: December 1, 2022
• Study Completion: February 5, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-01

Locations

IT (1)