Clinical trial NCT05863065: Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment
Official title: Personalized Virtual Reality Naturalistic Scenarios Promoting Engagement and Relaxation in Patients With Cognitive Impairment: a Proof-of-concept Mixed-methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Cognitive Decline
Cognitive Deterioration
Anxiety State
Keywords: virtual reality
personalized virtual scenario
user centered approach
mixed-methods study
user-experience
feasibility study
relaxation
anxiety
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Fondazione Bruno Kessler
name: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
name: TrentinoSalute4.0
First posted: 2023-05-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment.
timeFrame: Through study completion, an average of 6 months
measure: VR experience tolerability estimated based on the frequency of time spent in the VR context.
timeFrame: Through study completion, an average of 6 months
measure: Usability of the VR apparatus
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Change from before and after the one-shot VR session in the relaxation using the modified version of the State-Trait Anxiety Inventory-Y1 (STAI-Y1).
timeFrame: Through study completion, an average of 6 months
measure: Change from before and after the one-shot VR session in emotions felt using the Observed Emotion Rating Scale (OERS).
timeFrame: Through study completion, an average of 6 months
measure: Feedback about the perceived quality rating of the VR set-up deployed from health care staff
timeFrame: Through study completion, an average of 6 months
measure: Feedback about usability from health care staff
timeFrame: Through study completion, an average of 6 months
measure: Feedback about acceptability from health care staff
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
state: PD
city: Trento
country: Italy
facility: Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli"
state: TN
Study officials:
affiliation: University of Padova
name: Susanna Pardini, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova
name: Caterina Novara, PhD
role: PRINCIPAL_INVESTIGATOR
References: