Stress Related Disorder
Conditions
Keywords
virtual reality, stress, anxiety, prevention, treatment, relaxation techniques, psychoeducation, COVID-19, healthcare workers
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.
Interventions
BEHAVIORALVR 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).
OTHERControl (CR)
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
Sponsors
University of Milano Bicocca
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in score at the State-Trait Anxiety Inventory -Y2 | Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up | A 20 item measure of the level of the state anxiety |
| Change in score at the Perceived Stress Scale | 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 |
| Change in score at the Depression, Anxiety ans Stress Scale-21 items | 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 |
| Change in score of knowledge on stress and anxiety | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in score at the EQ-5D-5L | 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 |
Countries
Italy
Outcome results
None listed