Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

NCT ID: NCT05863065

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2023-03-06

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

Conditions

Cognitive Impairment; Cognitive Decline; Cognitive Deterioration; Anxiety State

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized Virtual Reality exposure

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

Group Type: EXPERIMENTAL

Exposure to a Virtual Reality scenarios

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Bruno Kessler

OTHER

Sponsor Role: collaborator

Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

OTHER

Sponsor Role: collaborator

TrentinoSalute4.0

OTHER

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Caterina Novara

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susanna Pardini, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Caterina Novara, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

University of Padova

Padua, PD, Italy

Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli"

Trento, TN, Italy

Countries

Italy

References

Pardini S, Gabrielli S, Gios L, Dianti M, Mayora-Ibarra O, Appel L, Olivetto S, Torres A, Rigatti P, Trentini E, Leonardelli L, Bernardi M, Lucianer M, Forti S, Novara C. Customized virtual reality naturalistic scenarios promoting engagement and relaxation in patients with cognitive impairment: a proof-of-concept mixed-methods study. Sci Rep. 2023 Nov 22;13(1):20516. doi: 10.1038/s41598-023-47876-1.

Reference Type: DERIVED

PMID: 37993549 (View on PubMed)

Other Identifiers

VR2022

Identifier Type: -

Identifier Source: org_study_id