Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863065
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2023-04-28
Brief Title:
Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Personalized Virtual Reality Naturalistic Scenarios Promoting Engagement and Relaxation in Patients With Cognitive Impairment a Proof-of-concept Mixed-methods Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this feasibility study is to investigate the feasibility of a personalized naturalistic Virtual Reality scenario by assessing motion-sickness effects engagement pleasantness and emotions felt considering a sample of individuals with cognitive impairment resident at the Azienda Pubblica di Servizi alla Persona APSP Margherita Grazioli a long-term care home in Trento Italy in collaboration with the Department of General Psychology - University of Padova Italy and the Centre for Health and Wellbeing-Fondazione Bruno Kessler Italy The current proof-of-concept and feasibility study is a one-session single-centre trial based on a mixed-methods approach inspired by the Obesity-Related Behavioral Intervention Trials ORBIT framework for the design Phase Ib of digital interventions and their preliminary testing Phase IIa
Detailed Description:
The impact of customizing VR scenarios is growing showing different kinds of positive effects such as an increased sense of presence and engagement in the virtual environment A relaxing and customizable VR environment could allow the management of any interfering environmental factors that might also be present in the natural context Additional investigations are still needed to obtain more consistent data on its feasibility and effectiveness
Considering this evidence the current proof-of-concept study is based on the following goals
evaluate the impact of VR on self-reported and observational levels of motion-sickness engagement and pleasantness in older adults living with cognitive impairment and residing in long-term care
investigate if personalized relaxing virtual environments can positively impact feelings and state anxiety
investigate the VR apparatuss usability from the health staffs perspective
Considering this evidence the current proof-of-concept study is based on the following goals
evaluate the impact of VR on self-reported and observational levels of motion-sickness engagement and pleasantness in older adults living with cognitive impairment and residing in long-term care
investigate if personalized relaxing virtual environments can positively impact feelings and state anxiety
investigate the VR apparatuss usability from the health staffs perspective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None