Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

University of Padova

Status: Completed

Conditions: Cognitive Impairment; Cognitive Decline; Cognitive Deterioration; Anxiety State

Treatments: Other: Exposure to a Virtual Reality scenarios

Study type: Interventional

Funder types: Other

Identifiers

NCT05863065

VR2022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Italian mother tongue
• Clinical diagnosis of Cognitive Impairment (mild, moderate, or severe).

Exclusion criteria

• Palliative care
• Clinical diagnosis of psychosis
• Severe neurological damage
• A clinical diagnosis of epilepsy (or having first-degree relatives diagnosed with epilepsy) - - Cardiac pacemaker or other metal devices
• Infectious or gastrointestinal disorders
• Open wounds at the level of the face
• Motor or visual dysfunctions and neuromuscular pain that prevent the use of Oculus.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Personalized Virtual Reality exposure

Experimental group

Description:

Participants are exposed to a personalized, relaxing VR scenario administered by the Oculus Quest 2 tool.

Treatment:

Other: Exposure to a Virtual Reality scenarios