Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study

NCT06693193 | Not Yet Recruiting DMC

• 1 other identifier: VR2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment. Specifically, the study will assess;

• feasibility through acceptance metrics (including recruitment rate, adherence rate, attrition rate, and tolerance to the intervention);
• safety (monitoring for adverse effects related to VR headset use);
• user engagement, enjoyment, and overall experience. Participants will be exposed to three VR sessions conducted before, during, or after a situation deemed activating (e.g., personal hygiene activities). Operators will conduct a baseline assessment to identify specific moments when the participant experiences responsive behaviors. Additionally, operators may administer the Oculus VR headset when responsive behaviors occur outside of baseline-identified moments.

Conditions

Cognitive Impairment; Dementia

Keywords

Customization; Customized Virtual Reality Scenarios; Cognitive Impairment; Responsive Behaviors; Virtual Reality Therapy; Non pharmacological therapy

Outcome Measures

Primary Outcomes (4)

• Feasibility based on the health staff operator perspective using the System Usability Scale (SUS)

  The SUS scale permitted the obtaining of information about the system's usability. The SUS range raw score from 0 to 100.

  From enrollment to the end of treatment at 3 weeks

• Feasibility using an Ad-hoc questionnaire

  The ad-hoc questionnaire permitted information about usability, engagement, satisfaction, and pleasure during exposure to the VR environment, as well as feelings and relaxation. The questionnaire is composed of 30 items based on a Likert scale from 1 to 5 (range score from 0 to 4), 15 items based on a Likert scale from 1 to 4 (range score from 0 to 3), and five open-ended questions.

  From enrollment to the end of treatment at 3 weeks

• Feasibility using the Non-pharmacological Therapy Experience Scale (NPT-ES)

  The NPT-ES permitted obtaining information about the subjective experience during the administration of non-pharmacological therapy. Five items are assessed on a Likert scale from 0 to 3. The total raw score is from 0 to 15.

  From enrollment to the end of treatment at 3 weeks

• Feasibility based on the health staff operator perspective using Focus Groups

  From enrollment to the end of treatment at 3 weeks

Secondary Outcomes (7)

• Assessment of the Responsive Behaviors administering the COHEN MANSFIELD - AGITATION INVENTORY (CMAI)

  From enrollment to the end of treatment at 3 weeks

• Assessment of the Responsive Behaviors administering the Functional Assessment Staging Tool (FAST)

  From enrollment to the end of treatment at 3 weeks

• Investigation of Adverse Symptoms Associated with Exposure to the Virtual Reality Device using the Virtual Reality Symptoms Questionnaire (VRSQ)

  From enrollment to the end of treatment at 3 weeks

• Pain experience assessment using the Pain Assessment in Advanced Dementia (PAINAD)

  From enrollment to the end of treatment at 3 weeks

• Assessment of the pharmacotherapy administration and the users'behaviors before or during the VR sessions using the DataSheet 2

  From enrollment to the end of treatment at 3 weeks

Other Outcomes (1)

• Assessment of Socio-demographic features using the Socio-demographic sheet

  From enrollment to the end of treatment at 3 weeks

Study Arms (1)

Virtual Reality group

EXPERIMENTAL

Participants will undergo three VR exposure sessions using Oculus headsets, presenting a virtual environment with realistic natural stimuli or customized environments tailored to individual preferences and valued activities. For each environment, auditory (e.g., animal sounds, wind rustling, type of music) and visual elements (e.g., presence of people, objects, or animals), as well as time of day and weather conditions, can be adjusted. The operator will customize the environment through a user-friendly smartphone app interface, enabling real-time parameter adjustments and content selection. During VR exposure, the operator can observe the participant's visual focus in real-time.

Device: Immersive Virtual Reality

Interventions

Immersive Virtual Reality DEVICE

Individuals will participate in three VR sessions using Oculus headsets, experiencing virtual environments featuring realistic natural stimuli or custom settings tailored to their preferences and valued activities. Each environment allows for the adjustment of auditory elements (such as animal sounds, rustling wind, or specific music), visual elements (such as people, objects, or animals), and the time of day and weather conditions. The operator will use a user-friendly smartphone app to customize the environment, making real-time adjustments to settings and content. Throughout the VR experience, the operator can monitor the participant's visual focus in real-time.

Virtual Reality group

Eligibility Criteria

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

You may qualify if:

• Adults over 18 years of age.
• Native Italian speakers.
• Can provide written informed consent for study participation or have a legal guardian who can give consent on their behalf.

You may not qualify if:

• Presence of any psychiatric diagnoses as recorded in medical records.
• A total score of ≥ 40 on the Neuropsychiatric Inventory (NPI) indicates neuropsychiatric symptoms.
• A partial NPI score \> 6 in the domains of agitation/aggression or delusions.
• Enrollment in palliative care services.
• Severe neurological damage, a positive diagnosis of epilepsy, or having first-degree relatives diagnosed with epilepsy.
• Presence of a cardiac pacemaker or other metallic devices.
• Infectious or gastrointestinal disorders.
• Open facial wounds, motor or visual impairments, or neuromuscular pain that would prevent using the Oculus VR headset.
• Refusal to consent, either by the individual or their legal representative, for study participation.

Sponsors & Collaborators

• Fondazione Bruno Kessler: lead

Study Sites (1)

APSP ''Grazioli''

Trento, Italy, 38123, Italy

Location

Related Publications (1)

• Pardini S, Gios L, Dianti M, Genovese A, Lamon M, Marcon J, Forti S, Mayora-Ibarra O. Exploring customised virtual environments in patients with cognitive decline and responsive behaviours: protocol for a proof-of-concept and feasibility study in a long-term care facility (iEMBRACE). BMJ Open. 2025 Dec 5;15(12):e098051. doi: 10.1136/bmjopen-2024-098051.

  PMID: 41360455 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Susanna Pardini

CONTACT

+39 0461314154; spardini@fbk.eu

Lorenzo Gios

CONTACT

lgios@fbk.eu

Study Design

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

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

IT (1)