- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04611399
MIND-VR: Virtual Reality for COVID-19-operatørers psykologiske støtte
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Siden COVID-19-pandemien begyndte, er adskillige psykologiske støtteprogrammer for sundhedspersonale blevet implementeret, især gruppe- eller individuelle rådgivningssessioner leveret ansigt til ansigt eller ved hjælp af telefoner og videokonferenceplatforme. Der er dog betydelige barrierer for leveringen af sådanne psykologiske initiativer. I denne sammenhæng anbefales digitale interventioner til at forbedre sundhedsydelser og plejeresultater til implementering og ydelse af fjernpsykologisk støtte.
Virtual reality kan spille en relevant rolle i at yde psykologisk pleje til sundhedspersonale, der står over for COVID-19. Ny kommerciel hovedmonteret skærm har gjort virtual reality tilgængelig selv for massepublikummet, og nedbryder barriererne i spredningen og brugen af denne teknologi. Takket være denne kendsgerning kan virtual reality nu bruges selvstændigt af mennesker og tilbydes at yde psykologisk assistance eksternt.
Inden for denne sammenhæng har dette randomiserede kontrollerede forsøg (RCT) til formål at undersøge effektiviteten af et virtual reality-hjemmebaseret program til at mindske stress og angst hos et udvalg af italienske sundhedsarbejdere involveret i COVID-19-pandemien. Målet er især at sammenligne effektiviteten af denne type træning med hensyn til det samme program uden virtual reality og en venteliste.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Milan, Italien, 20133
- Fondazione IRCCS Istituto Neurologico Carlo Besta
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Alder > 18, < 65;
- At have arbejdet i frontlinjen som læge eller sygeplejerske under COVID-19-nødsituationen (dvs. have assisteret COVID-19-patienter eller have arbejdet i afdelinger dedikeret til COVID-19-patienter);
- Normal eller korrigeret til normal synsstyrke;
- Normal eller korrigeret til normal høreevne.
Ekskluderingskriterier:
- Fysisk sygdom: kardiovaskulære problemer, neurologisk sygdom, epilepsi;
- Farmakoterapi med: psykofarmaka, antihypertensiva, antiepileptika;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Virtual Reality (VR) gruppe
Behandlingen for deltagerne tildelt VR Gruppen består af tre hjemmesessioner på ca. 30 minutter hver, afviklet over en uge.
I hver session vil deltagerne blive bedt om at prøve i cirka 15 minutter "MIND-VR".
Efterfølgende vil de prøve det virtuelle afslapningsindhold "Den hemmelige have".
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Brug af specifikt udviklet VR-indhold til at levere psykoedukativt indhold om stress og angst (dvs. "MIND-VR") og til at træne i afspændingsteknikker (dvs. "Den hemmelige have").
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Aktiv komparator: Kontrolgruppe (CR).
CR-gruppen vil gennemgå præ- og post-protokoltest uden at gennemgå nogen behandling.
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CR-gruppen vil gennemgå præ- og post-protokoltest uden at gennemgå nogen behandling.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring i score på State-Trait Anxiety Inventory -Y2
Tidsramme: Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Et mål på 20 punkter for niveauet af tilstandsangst
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Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Ændring i score på Perceived Stress Scale
Tidsramme: Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Et mål på 10 punkter for niveauet af stress oplevet i den sidste måned
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Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Ændring i score på Depression, Angst og Stress Scale-21 elementer
Tidsramme: Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Et 21 punkt i 3 selvrapporteringsskalaer, som måler depression, angst og stress
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Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Ændring i score af viden om stress og angst
Tidsramme: Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Et 7-punkts mål ved ad hoc-spørgeskemaet for at vurdere viden om stress og angst
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Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring i score på EQ-5D-5L
Tidsramme: Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Et mål, der definerer sundhedstilstanden og den oplevede livskvalitet
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Baseline; umiddelbart efter indgrebet/indgrebet; 3 måneder og 6 måneders opfølgning
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Federica Pallavicini, PhD, University of Milano Bicocca
- Ledende efterforsker: Eleonora F Orena, PhD, Foundation IRCCS Neurological Institute Carlo Besta
Publikationer og nyttige links
Generelle publikationer
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Qiu J, Shen B, Zhao M, Wang Z, Xie B, Xu Y. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: implications and policy recommendations. Gen Psychiatr. 2020 Mar 6;33(2):e100213. doi: 10.1136/gpsych-2020-100213. eCollection 2020. Erratum In: Gen Psychiatr. 2020 Apr 27;33(2):e100213corr1.
- Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218.
- Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available. Erratum In: Lancet Psychiatry. 2020 May;7(5):e27.
- Kang L, Li Y, Hu S, Chen M, Yang C, Yang BX, Wang Y, Hu J, Lai J, Ma X, Chen J, Guan L, Wang G, Ma H, Liu Z. The mental health of medical workers in Wuhan, China dealing with the 2019 novel coronavirus. Lancet Psychiatry. 2020 Mar;7(3):e14. doi: 10.1016/S2215-0366(20)30047-X. Epub 2020 Feb 5. No abstract available.
- Riva G, Vigna C, Grassi A, Raspelli S, Cipresso P, Pallavicini F, Serino S, Gaggioli A. Learning Island: the development of a virtual reality system for the experiential training of stress management. Stud Health Technol Inform. 2012;173:369-71.
- Rothbaum BO, Hodges LF, Kooper R, Opdyke D, Williford JS, North M. Effectiveness of computer-generated (virtual reality) graded exposure in the treatment of acrophobia. Am J Psychiatry. 1995 Apr;152(4):626-8. doi: 10.1176/ajp.152.4.626.
- Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.
- 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.
- 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.
- Bailenson, J. N., Yee, N., Blascovich, J., Beall, A. C., Lundblad, N., & Jin, M. (2008). The Use of Immersive Virtual Reality in the Learning Sciences: Digital Transformations of Teachers, Students, and Social Context. Journal of the Learning Sciences, 17(1), 102-141.
- Bakker M, Wicherts JM. The (mis)reporting of statistical results in psychology journals. Behav Res Methods. 2011 Sep;43(3):666-78. doi: 10.3758/s13428-011-0089-5.
- Bangor, A., Kortum, P. T., & Miller, J. T. (2008). An Empirical Evaluation of the System Usability Scale. International Journal of Human-Computer Interaction, 24(6), 574-594.
- Basso JC, Suzuki WA. The Effects of Acute Exercise on Mood, Cognition, Neurophysiology, and Neurochemical Pathways: A Review. Brain Plast. 2017 Mar 28;2(2):127-152. doi: 10.3233/BPL-160040.
- Beck JG, Palyo SA, Winer EH, Schwagler BE, Ang EJ. Virtual Reality Exposure Therapy for PTSD symptoms after a road accident: an uncontrolled case series. Behav Ther. 2007 Mar;38(1):39-48. doi: 10.1016/j.beth.2006.04.001. Epub 2006 Sep 22.
- Botella C, Serrano B, Banos RM, Garcia-Palacios A. Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability. Neuropsychiatr Dis Treat. 2015 Oct 3;11:2533-45. doi: 10.2147/NDT.S89542. eCollection 2015.
- Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
- De Freitas, S., Rebolledo-Mendez, G., Liarokapis, F., Magoulas, G., & Poulovassilis, A. (2010). Learning as immersive experiences: Using the four-dimensional framework for designing and evaluating immersive learning experiences in a virtual world. British Journal of Educational Technology, 41(1),69-85.
- Difede J, Cukor J, Jayasinghe N, Patt I, Jedel S, Spielman L, Giosan C, Hoffman HG. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder following September 11, 2001. J Clin Psychiatry. 2007 Nov;68(11):1639-47.
- Difede J, Cukor J, Wyka K, Olden M, Hoffman H, Lee FS, Altemus M. D-cycloserine augmentation of exposure therapy for post-traumatic stress disorder: a pilot randomized clinical trial. Neuropsychopharmacology. 2014 Apr;39(5):1052-8. doi: 10.1038/npp.2013.317. Epub 2013 Nov 12.
- Duan YY, Zhang JY, Xie M, Feng XB, Xu S, Ye ZW. Application of Virtual Reality Technology in Disaster Medicine. Curr Med Sci. 2019 Oct;39(5):690-694. doi: 10.1007/s11596-019-2093-4. Epub 2019 Oct 14. Erratum In: Curr Med Sci. 2020 Dec;40(6):1205.
- Fish, M. T., Russoniello, C. V., & O'Brien, K. (2018). Zombies vs. Anxiety: An Augmentation Study of Prescribed Video Game Play Compared to Medication in Reducing Anxiety Symptoms. Simulation & Gaming, 49(5), 553-566.
- Fujii S, Kato H, Maeda K. A simple interview-format screening measure for disaster mental health: an instrument newly developed after the 1995 Great Hanshin Earthquake in Japan--the Screening Questionnaire for Disaster Mental Health (SQD). Kobe J Med Sci. 2008 Feb 8;53(6):375-85.
- Gaggioli A, Pallavicini F, Morganti L, Serino S, Scaratti C, Briguglio M, Crifaci G, Vetrano N, Giulintano A, Bernava G, Tartarisco G, Pioggia G, Raspelli S, Cipresso P, Vigna C, Grassi A, Baruffi M, Wiederhold B, Riva G. Experiential virtual scenarios with real-time monitoring (interreality) for the management of psychological stress: a block randomized controlled trial. J Med Internet Res. 2014 Jul 8;16(7):e167. doi: 10.2196/jmir.3235.
- Gerardi M, Rothbaum BO, Ressler K, Heekin M, Rizzo A. Virtual reality exposure therapy using a virtual Iraq: case report. J Trauma Stress. 2008 Apr;21(2):209-13. doi: 10.1002/jts.20331.
- Gorini A, Griez E, Petrova A, Riva G. Assessment of the emotional responses produced by exposure to real food, virtual food and photographs of food in patients affected by eating disorders. Ann Gen Psychiatry. 2010 Jul 5;9:30. doi: 10.1186/1744-859X-9-30.
- Gradl, S., Wirth, M., Zillig, T., & Eskofier, B. M. (2018). Visualization of heart activity in virtual reality: A biofeedback application using wearable sensors. In 2018 IEEE 15th International Conference on Wearable and Implantable Body Sensor Networks (BSN) (pp. 152-155). IEEE.
- Granic I, Lobel A, Engels RC. The benefits of playing video games. Am Psychol. 2014 Jan;69(1):66-78. doi: 10.1037/a0034857. Epub 2013 Dec 2.
- Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.
- Heiman, G. W. (1998). Understanding research methods and statistics : an integrated introduction for psychology.
- Hoffman HG. Virtual-reality therapy. Sci Am. 2004 Aug;291(2):58-65. doi: 10.1038/scientificamerican0804-58. No abstract available.
- Huang JZ, Han MF, Luo TD, Ren AK, Zhou XP. [Mental health survey of medical staff in a tertiary infectious disease hospital for COVID-19]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2020 Mar 20;38(3):192-195. doi: 10.3760/cma.j.cn121094-20200219-00063. Chinese.
- Lee KM, Gilmore DF. Statistical experimental design for bioprocess modeling and optimization analysis: repeated-measures method for dynamic biotechnology process. Appl Biochem Biotechnol. 2006 Nov;135(2):101-16. doi: 10.1385/abab:135:2:101.
- Li Z, Ge J, Yang M, Feng J, Qiao M, Jiang R, Bi J, Zhan G, Xu X, Wang L, Zhou Q, Zhou C, Pan Y, Liu S, Zhang H, Yang J, Zhu B, Hu Y, Hashimoto K, Jia Y, Wang H, Wang R, Liu C, Yang C. Vicarious traumatization in the general public, members, and non-members of medical teams aiding in COVID-19 control. Brain Behav Immun. 2020 Aug;88:916-919. doi: 10.1016/j.bbi.2020.03.007. Epub 2020 Mar 10.
- Lindner P, Miloff A, Hamilton W, Carlbring P. The Potential of Consumer-Targeted Virtual Reality Relaxation Applications: Descriptive Usage, Uptake and Application Performance Statistics for a First-Generation Application. Front Psychol. 2019 Feb 4;10:132. doi: 10.3389/fpsyg.2019.00132. eCollection 2019.
- Liu CY, Yang YZ, Zhang XM, Xu X, Dou QL, Zhang WW, Cheng ASK. The prevalence and influencing factors in anxiety in medical workers fighting COVID-19 in China: a cross-sectional survey. Epidemiol Infect. 2020 May 20;148:e98. doi: 10.1017/S0950268820001107.
- McAlonan GM, Lee AM, Cheung V, Cheung C, Tsang KW, Sham PC, Chua SE, Wong JG. Immediate and sustained psychological impact of an emerging infectious disease outbreak on health care workers. Can J Psychiatry. 2007 Apr;52(4):241-7. doi: 10.1177/070674370705200406.
- McLay RN, Wood DP, Webb-Murphy JA, Spira JL, Wiederhold MD, Pyne JM, Wiederhold BK. A randomized, controlled trial of virtual reality-graded exposure therapy for post-traumatic stress disorder in active duty service members with combat-related post-traumatic stress disorder. Cyberpsychol Behav Soc Netw. 2011 Apr;14(4):223-9. doi: 10.1089/cyber.2011.0003. Epub 2011 Feb 20.
- Oing T, Prescott J. Implementations of Virtual Reality for Anxiety-Related Disorders: Systematic Review. JMIR Serious Games. 2018 Nov 7;6(4):e10965. doi: 10.2196/10965.
- Pallavicini F, Gaggioli A, Raspelli S, Cipresso P, Serino S, Vigna C, Grassi A, Morganti L, Baruffi M, Wiederhold B, Riva G. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial. Trials. 2013 Jun 28;14:191. doi: 10.1186/1745-6215-14-191.
- Pallavicini, F., Algeri, D., Repetto, C., Gorini, A., & Riva, G. (2009). Biofeedback, virtual reality and mobile phones in the treatment of generalized anxiety disorder (gad): A phase-2 controlled clinical trial. Journal of Cyber Therapy and Rehabilitation, 2(4), 315-327.
- Pallavicini F, Cipresso P, Raspelli S, Grassi A, Serino S, Vigna C, Triberti S, Villamira M, Gaggioli A, Riva G. Is virtual reality always an effective stressors for exposure treatments? Some insights from a controlled trial. BMC Psychiatry. 2013 Feb 11;13:52. doi: 10.1186/1471-244X-13-52.
- Pallavicini, F., Ferrari, A., Zini, A., Garcea, G., Zanacchi, A., Barone, G., & Mantovani, F. (2018). What Distinguishes a Traditional Gaming Experience from One in Virtual Reality? An Exploratory Study (pp. 225-231). Springer, Cham.
- Pallavicini, F., & Pepe, A. (2019). Comparing Player Experience in Video Games Played in Virtual Reality or on Desktop Displays. In Extended Abstracts of the Annual Symposium on Computer-Human Interaction in Play Companion Extended Abstracts - CHI PLAY '19 Extended Abstracts (pp. 195-210). New York, New York, USA: ACM Press.
- Pallavicini, F, Pepe, A., & Minissi, M. E. (2019). Gaming in Virtual Reality: What Changes in Terms of Usability, Emotional Response and Sense of Presence Compared to Non-Immersive Video Games? Simulation & Gaming, 104687811983142.
- Pallavicini F, Pepe A. Virtual Reality Games and the Role of Body Involvement in Enhancing Positive Emotions and Decreasing Anxiety: Within-Subjects Pilot Study. JMIR Serious Games. 2020 Jun 17;8(2):e15635. doi: 10.2196/15635.
- Parong, J., Mayer, R. E., Fiorella, L., MacNamara, A., Homer, B. D., & Plass, J. L. (2017). Learning executive function skills by playing focused video games. Contemporary Educational Psychology, 51, 141-151.
- Pedram, S., Palmisano, S., Perez, P., Mursic, R., & Farrelly, M. (2020). Examining the potential of virtual reality to deliver remote rehabilitation. Computers in Human Behavior, 105, 106223.
- Pizzoli SFM, Mazzocco K, Triberti S, Monzani D, Alcaniz Raya ML, Pravettoni G. User-Centered Virtual Reality for Promoting Relaxation: An Innovative Approach. Front Psychol. 2019 Mar 12;10:479. doi: 10.3389/fpsyg.2019.00479. eCollection 2019.
- Powers MB, Asmundson GJ, Smits JA. Exercise for Mood and Anxiety Disorders: The State-of-the Science. Cogn Behav Ther. 2015;44(4):237-9. doi: 10.1080/16506073.2015.1047286. No abstract available.
- Quesnel D, Riecke BE. Are You Awed Yet? How Virtual Reality Gives Us Awe and Goose Bumps. Front Psychol. 2018 Nov 9;9:2158. doi: 10.3389/fpsyg.2018.02158. eCollection 2018.
- Repetto C, Gorini A, Vigna C, Algeri D, Pallavicini F, Riva G. The use of biofeedback in clinical virtual reality: the INTREPID project. J Vis Exp. 2009 Nov 12;(33):1554. doi: 10.3791/1554.
- Riva G, Wiederhold BK. How Cyberpsychology and Virtual Reality Can Help Us to Overcome the Psychological Burden of Coronavirus. Cyberpsychol Behav Soc Netw. 2020 May;23(5):277-279. doi: 10.1089/cyber.2020.29183.gri. Epub 2020 Apr 17. No abstract available.
- Rizzo A, Parsons TD, Lange B, Kenny P, Buckwalter JG, Rothbaum B, Difede J, Frazier J, Newman B, Williams J, Reger G. Virtual reality goes to war: a brief review of the future of military behavioral healthcare. J Clin Psychol Med Settings. 2011 Jun;18(2):176-87. doi: 10.1007/s10880-011-9247-2.
- Shin M, Heard R, Suo C, Chow CM. Positive Emotions Associated with "Counter-Strike" Game Playing. Games Health J. 2012 Oct;1(5):342-7. doi: 10.1089/g4h.2012.0010.
- Stetz MC, Kaloi-Chen JY, Turner DD, Bouchard S, Riva G, Wiederhold BK. The effectiveness of technology-enhanced relaxation techniques for military medical warriors. Mil Med. 2011 Sep;176(9):1065-70. doi: 10.7205/milmed-d-10-00393.
- Valdez P, Mehrabian A. Effects of color on emotions. J Exp Psychol Gen. 1994 Dec;123(4):394-409. doi: 10.1037//0096-3445.123.4.394.
- Walshe DG, Lewis EJ, Kim SI, O'Sullivan K, Wiederhold BK. Exploring the use of computer games and virtual reality in exposure therapy for fear of driving following a motor vehicle accident. Cyberpsychol Behav. 2003 Jun;6(3):329-34. doi: 10.1089/109493103322011641.
- Wechsler TF, Kumpers F, Muhlberger A. Inferiority or Even Superiority of Virtual Reality Exposure Therapy in Phobias?-A Systematic Review and Quantitative Meta-Analysis on Randomized Controlled Trials Specifically Comparing the Efficacy of Virtual Reality Exposure to Gold Standard in vivo Exposure in Agoraphobia, Specific Phobia, and Social Phobia. Front Psychol. 2019 Sep 10;10:1758. doi: 10.3389/fpsyg.2019.01758. eCollection 2019.
- Zhu J, Sun L, Zhang L, Wang H, Fan A, Yang B, Li W, Xiao S. Prevalence and Influencing Factors of Anxiety and Depression Symptoms in the First-Line Medical Staff Fighting Against COVID-19 in Gansu. Front Psychiatry. 2020 Apr 29;11:386. doi: 10.3389/fpsyt.2020.00386. eCollection 2020. Erratum In: Front Psychiatry. 2021 Mar 24;12:653709.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MIND-VR/Besta
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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