Clinical trial NCT04611399: MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support
Official title: MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Related Disorder
Keywords: virtual reality
stress
anxiety
prevention
treatment
relaxation techniques
psychoeducation
COVID-19
healthcare workers
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2020-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change in score at the State-Trait Anxiety Inventory -Y2
timeFrame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
measure: Change in score at the Perceived Stress Scale
timeFrame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
measure: Change in score at the Depression, Anxiety ans Stress Scale-21 items
timeFrame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
measure: Change in score of knowledge on stress and anxiety
timeFrame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Secondary outcomes:
measure: Change in score at the EQ-5D-5L
timeFrame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
Study officials:
affiliation: University of Milano Bicocca
name: Federica Pallavicini, PhD
role: STUDY_DIRECTOR
affiliation: Foundation IRCCS Neurological Institute Carlo Besta
name: Eleonora F Orena, PhD
role: PRINCIPAL_INVESTIGATOR
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