Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

NCT05863065 | Completed DMC

• 1 other identifier: VR2022
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (3)

• Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment.

  To assess these symptoms, the Virtual Reality Symptom Questionnaire (VRSQ) was used. The score assigned to each item ranges from 0 to 6, with a maximum total score of 84 (48 for general symptoms and 36 for eye symptoms). Higher scores represent worse symptoms, with 0 corresponding to no adverse effects, and 84 to serious adverse effects.

  Through study completion, an average of 6 months

• VR experience tolerability estimated based on the frequency of time spent in the VR context.

  The VR experience tolerability was estimated based on the frequency of time spent in the VR context.

  Through study completion, an average of 6 months

• Usability of the VR apparatus

  The usability has been investigated by a measure developed and described by Appel et al. (2020) composed of both self-reported questions and other queries that the experimenter answered by observing the participant's behavior during the experience and characterized by a series of items based on a 5 points Likert scale (Questions about Level of interest, awareness, engagement, and enjoyment observed: 1="very much", 5="not at all"; min. score=5 and max. score=25; higher scores mean a worse outcome. Questions on other information in relation to the VR experience: 1= "strongly disagree", 5= "strongly agree"; min. score=17 and max. score=85; higher scores mean a better outcome), and six open-ended questions focalized in obtaining additional information, where possible, about: 1) what participants liked best and least; 2) what participants would like to see; 3) if participants would like to repeat the experience; 4) if participants would recommend the experience to a friend.

  Through study completion, an average of 6 months

Secondary Outcomes (5)

• 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).

  Through study completion, an average of 6 months

• Change from before and after the one-shot VR session in emotions felt using the Observed Emotion Rating Scale (OERS).

  Through study completion, an average of 6 months

• Feedback about the perceived quality rating of the VR set-up deployed from health care staff

  Through study completion, an average of 6 months

• Feedback about usability from health care staff

  Through study completion, an average of 6 months

• Feedback about acceptability from health care staff

  Through study completion, an average of 6 months

Study Arms (1)

Personalized Virtual Reality exposure

EXPERIMENTAL

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

Other: Exposure to a Virtual Reality scenarios

Interventions

Exposure to a Virtual Reality scenarios 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.

Personalized Virtual Reality exposure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead
• Fondazione Bruno Kessler: collaborator
• Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento: collaborator
• TrentinoSalute4.0: collaborator

Study Sites (2)

University of Padova

Padua, PD, 35131, Italy

Location

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

Trento, TN, Italy

Location

Related Publications (1)

• 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.

  PMID: 37993549 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Susanna Pardini, PsyD

  University of Padova

  PRINCIPAL INVESTIGATOR

• Caterina Novara, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 17, 2023
• Study Start: January 23, 2023
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)