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| Name | Class |
|---|---|
| University of Milano Bicocca | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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". |
|
| Control (CR) Group | Active Comparator | The CR Group will undergo pre- and post-protocol tests without undergoing any treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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"). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federica Pallavicini, PhD | University of Milano Bicocca | Study Director |
| Eleonora F Orena, PhD | Foundation IRCCS Neurological Institute Carlo Besta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28539139 | Background | Anderson AP, Mayer MD, Fellows AM, Cowan DR, Hegel MT, Buckey JC. Relaxation with Immersive Natural Scenes Presented Using Virtual Reality. Aerosp Med Hum Perform. 2017 Jun 1;88(6):520-526. doi: 10.3357/AMHP.4747.2017. | |
| 23630504 | Background | Anderson E, Shivakumar G. Effects of exercise and physical activity on anxiety. Front Psychiatry. 2013 Apr 23;4:27. doi: 10.3389/fpsyt.2013.00027. eCollection 2013. No abstract available. |
| Label | URL |
|---|---|
| Johns Hopkins Coronavirus Resource Center. (2020). COVID-19 Map. | View source |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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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).
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| Control (CR) | Other | The CR Group will undergo pre- and post-protocol tests without undergoing any treatment. |
|
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| 40053782 | Derived | Pallavicini F, Orena E, Arnoldi L, Achille F, Stefanini S, Cassa M, Pepe A, Veronese G, Bernardelli L, Sforza F, Fascendini S, Defanti CA, Gemma M, Clerici M, Riva G, Mantovani F. Effects and Acceptability of a 1-Week Home-Based Virtual Reality Training for Supporting the Management of Stress and Anxiety: Randomized Pilot Trial. JMIR Serious Games. 2025 Mar 6;13:e50326. doi: 10.2196/50326. |
| 35655231 | 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. |
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| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |