Effect of an intensive care unit virtual reality intervention on relatives´ mental health distress:a multicenter, randomized controlled trial

BACKGROUND: Relatives of intensive care unit (ICU) patients often endure symptoms of post-traumatic stress, anxiety, and depression during and after treatment of a family member's hospitalization. The aim of this study was to evaluate the effect of ICU-specific virtual reality (ICU-VR) on mental health among relatives, 6 months after patient's ICU discharge.METHODS: This multicenter, randomized controlled trial included relatives of ICU patients who were assigned to receive either standard care or standard care plus ICU-VR, by randomizing the ICU patients. Relatives were assessed up to 6 months after patient discharge from the ICU for post-traumatic stress, anxiety, depression, quality of life, relatives' understanding of ICU care, and appreciation of ICU-VR.RESULTS: One hundred relatives of 81 patients and 89 relatives of 80 patients were randomized to the intervention and control groups, respectively. Relatives' median age was 48 years and 53% were female. Compared to the control group, relatives who received ICU-VR did not experience a decrease in post-traumatic stress (23% vs. 18%; p = 0.99), anxiety (22% vs. 30%; p = 0.35), or depression (17% vs. 23%; p = 0.44). There was no significant difference between median mental quality of life (50.2 vs. 52.6; p = 0.51), physical quality of life (56.1 vs. 54.3; p = 0.16), or understanding of ICU care between groups. Patients in the intervention group highly endorsed ICU-VR (90%), favoring it over traditional informational brochures and the majority (82%) stated it improved their understanding of ICU treatment.CONCLUSION: ICU-VR did not significantly improve mental health distress symptoms among relatives 6-months after a patient's discharge. Relatives highly endorsed ICU-VR and self-reported that it improved their understanding of ICU treatment.</p

Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline

Background: Extended reality (XR), encompassing technologies such as virtual reality, augmented reality, and mixed reality, has rapidly gained prominence in health care. However, existing XR research often lacks rigor, proper controls, and standardization. Objective: To address this and to enhance the transparency and quality of reporting in early-phase clinical evaluations of XR applications, we present the “Reporting for the early-phase clinical evaluation of applications using extended reality” (RATE-XR) guideline. Methods: We conducted a 2-round modified Delphi process involving experts from diverse stakeholder categories, and the RATE-XR is therefore the result of a consensus-based, multistakeholder effort. Results: The guideline comprises 17 XR-specific (composed of 18 subitems) and 14 generic reporting items, each with a complementary Explanation & Elaboration section. Conclusions: The items encompass critical aspects of XR research, from clinical utility and safety to human factors and ethics. By offering a comprehensive checklist for reporting, the RATE-XR guideline facilitates robust assessment and replication of early-stage clinical XR studies. It underscores the need for transparency, patient-centeredness, and balanced evaluation of the applications of XR in health care. By providing an actionable checklist of minimal reporting items, this guideline will facilitate the responsible development and integration of XR technologies into health care and related fields

RATE-XR

Reporting eArly-phase sTudies Evaluating eXtended Reality applications in healthcare guidelin

RATE-XR

Reporting eArly-phase sTudies Evaluating eXtended Reality applications in healthcare guidelin

Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline

BackgroundExtended reality (XR), encompassing technologies such as virtual reality, augmented reality, and mixed reality, has rapidly gained prominence in health care. However, existing XR research often lacks rigor, proper controls, and standardization. ObjectiveTo address this and to enhance the transparency and quality of reporting in early-phase clinical evaluations of XR applications, we present the “Reporting for the early-phase clinical evaluation of applications using extended reality” (RATE-XR) guideline. MethodsWe conducted a 2-round modified Delphi process involving experts from diverse stakeholder categories, and the RATE-XR is therefore the result of a consensus-based, multistakeholder effort. ResultsThe guideline comprises 17 XR-specific (composed of 18 subitems) and 14 generic reporting items, each with a complementary Explanation & Elaboration section. ConclusionsThe items encompass critical aspects of XR research, from clinical utility and safety to human factors and ethics. By offering a comprehensive checklist for reporting, the RATE-XR guideline facilitates robust assessment and replication of early-stage clinical XR studies. It underscores the need for transparency, patient-centeredness, and balanced evaluation of the applications of XR in health care. By providing an actionable checklist of minimal reporting items, this guideline will facilitate the responsible development and integration of XR technologies into health care and related fields