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

Primary Purpose

Stress Related Disorder

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
VR for psychoeducation and relaxation
Control (CR)
Sponsored by
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Related Disorder focused on measuring virtual reality, stress, anxiety, prevention, treatment, relaxation techniques, psychoeducation, COVID-19, healthcare workers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality (VR) Group

Control (CR) Group

Arm Description

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".

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

Outcomes

Primary Outcome Measures

Change in score at the State-Trait Anxiety Inventory -Y2
A 20 item measure of the level of the state anxiety
Change in score at the Perceived Stress Scale
A 10 item measure of the level of stress perceived in the last month
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
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

Secondary Outcome Measures

Change in score at the EQ-5D-5L
A measure which defines the state of health and the perceived quality of life

Full Information

First Posted
October 8, 2020
Last Updated
June 1, 2023
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT04611399
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators
University of Milano Bicocca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Related Disorder
Keywords
virtual reality, stress, anxiety, prevention, treatment, relaxation techniques, psychoeducation, COVID-19, healthcare workers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality (VR) Group
Arm Type
Experimental
Arm Description
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".
Arm Title
Control (CR) Group
Arm Type
Active Comparator
Arm Description
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
Intervention Type
Behavioral
Intervention Name(s)
VR for psychoeducation and relaxation
Intervention Description
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").
Intervention Type
Other
Intervention Name(s)
Control (CR)
Intervention Description
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
Primary Outcome Measure Information:
Title
Change in score at the State-Trait Anxiety Inventory -Y2
Description
A 20 item measure of the level of the state anxiety
Time Frame
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Title
Change in score at the Perceived Stress Scale
Description
A 10 item measure of the level of stress perceived in the last month
Time Frame
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Title
Change in score at the Depression, Anxiety ans Stress Scale-21 items
Description
A 21 item in 3 self-report scales which measures depression, anxiety and stress
Time Frame
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Title
Change in score of knowledge on stress and anxiety
Description
A 7 item measure at the ad hoc questionnaire to assess the knowledge of stress and anxiety
Time Frame
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Secondary Outcome Measure Information:
Title
Change in score at the EQ-5D-5L
Description
A measure which defines the state of health and the perceived quality of life
Time Frame
Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federica Pallavicini, PhD
Organizational Affiliation
University of Milano Bicocca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eleonora F Orena, PhD
Organizational Affiliation
Foundation IRCCS Neurological Institute Carlo Besta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta
City
Milan
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

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

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