NCT05863065

Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

Personalized Virtual Reality Naturalistic Scenarios Promoting Engagement and Relaxation in Patients With Cognitive Impairment: a Proof-of-concept Mixed-methods Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 apparatus's usability from the health staff's perspective.

Conditions

• Cognitive Impairment
• Cognitive Decline
• Cognitive Deterioration
• Anxiety State

Interventions

Type	Name	Description
OTHER	Exposure to a Virtual Reality scenarios	Exposure to a personalized, relaxing Virtual Reality scenario deployed by a Head-mounted tool (Oculus Quest 2). The administration was deployed in one session.

Timeline

• Start date: 2023-01-23
• Primary completion: 2023-03-06
• Completion: 2023-03-06
• First posted: 2023-05-17
• Last updated: 2023-05-17

Locations

2 sites across 1 country: Italy