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Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

Primary Purpose

Cognitive Impairment, Cognitive Decline, Cognitive Deterioration

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Exposure to a Virtual Reality scenarios
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring virtual reality, personalized virtual scenario, user centered approach, mixed-methods study, user-experience, feasibility study, relaxation, anxiety

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Padova
  • Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Personalized Virtual Reality exposure

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
The modified version of the State-Trait Anxiety Inventory-Y1 (STAI-Y1), inspired by Appel et al.16,17, was administered in this study to obtain information on the state-anxiety level experienced before and after the VR session. The scale was administered as an interview based on a 5-point Likert scale from 1 (not at all) to 5 (a lot); min. score=15; max. score=75. Higher scores mean a worse outcome.
Change from before and after the one-shot VR session in emotions felt using the Observed Emotion Rating Scale (OERS).
The Observed Emotion Rating Scale (OERS) was adapted from the original version of Lawton et al.41 and used as an observation tool to assess the presence and frequency of negative emotions (fear, anxiety, anger, and sadness) and positive (pleasure) feelings experienced during the session based on a scale from 1 to 5 (1: "undetected emotion"; 2: "emotion observed for less than 16 seconds"; 3: "emotion observed for 16-59 seconds"; 4: "emotion observed for 1-5 minutes"; 5: "emotion observed for more than 5 minutes").
Feedback about the perceived quality rating of the VR set-up deployed from health care staff
To obtain information from health professionals about the perceived quality rating of the VR set-up deployed, the Adapting-Mobile App Rating Scale (A-MARS)-Subjective Quality Scale was filled in by operators who participated during the VR sessions. The administration was performed at the end of the administration of the experimental procedure. (Likert scale from 1 to 5; min.score=4 and max.score=25; higher scores mean a better outcome).
Feedback about usability from health care staff
To obtain information from health professionals about usability of the VR set-up deployed, the System Usability Scale (SUS) was filled in by operators who participated during the VR sessions. The administration was performed after the administration of the experimental procedure. The SUS consists of a 10 item questionnaire on a 5-points Likert scale (1: Strongly agree; 5: Strongly disagree). The score for each question is converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores mean a better outcome.
Feedback about acceptability from health care staff
To obtain information from health professionals about acceptability, at the end of the experimental phase, a focus group was conducted with the health professionals that assisted users during the VR experience. Issues discussed during the focus group were the strengths and weaknesses associated with using virtual reality, the future perspectives, and the risks associated with using virtual reality with users affected by cognitive impairment.

Full Information

First Posted
April 28, 2023
Last Updated
May 8, 2023
Sponsor
University of Padova
Collaborators
Fondazione Bruno Kessler, Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento, TrentinoSalute4.0
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1. Study Identification

Unique Protocol Identification Number
NCT05863065
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova
Collaborators
Fondazione Bruno Kessler, Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento, TrentinoSalute4.0

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized Virtual Reality exposure
Arm Type
Experimental
Arm Description
Participants are exposed to a personalized, relaxing VR scenario administered by the Oculus Quest 2 tool.
Intervention Type
Other
Intervention Name(s)
Exposure to a Virtual Reality scenarios
Intervention Description
Exposure to a personalized, relaxing Virtual Reality scenario deployed by a Head-mounted tool (Oculus Quest 2). The administration was deployed in one session.
Primary Outcome Measure Information:
Title
Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment.
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
VR experience tolerability estimated based on the frequency of time spent in the VR context.
Description
The VR experience tolerability was estimated based on the frequency of time spent in the VR context.
Time Frame
Through study completion, an average of 6 months
Title
Usability of the VR apparatus
Description
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.
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
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).
Description
The modified version of the State-Trait Anxiety Inventory-Y1 (STAI-Y1), inspired by Appel et al.16,17, was administered in this study to obtain information on the state-anxiety level experienced before and after the VR session. The scale was administered as an interview based on a 5-point Likert scale from 1 (not at all) to 5 (a lot); min. score=15; max. score=75. Higher scores mean a worse outcome.
Time Frame
Through study completion, an average of 6 months
Title
Change from before and after the one-shot VR session in emotions felt using the Observed Emotion Rating Scale (OERS).
Description
The Observed Emotion Rating Scale (OERS) was adapted from the original version of Lawton et al.41 and used as an observation tool to assess the presence and frequency of negative emotions (fear, anxiety, anger, and sadness) and positive (pleasure) feelings experienced during the session based on a scale from 1 to 5 (1: "undetected emotion"; 2: "emotion observed for less than 16 seconds"; 3: "emotion observed for 16-59 seconds"; 4: "emotion observed for 1-5 minutes"; 5: "emotion observed for more than 5 minutes").
Time Frame
Through study completion, an average of 6 months
Title
Feedback about the perceived quality rating of the VR set-up deployed from health care staff
Description
To obtain information from health professionals about the perceived quality rating of the VR set-up deployed, the Adapting-Mobile App Rating Scale (A-MARS)-Subjective Quality Scale was filled in by operators who participated during the VR sessions. The administration was performed at the end of the administration of the experimental procedure. (Likert scale from 1 to 5; min.score=4 and max.score=25; higher scores mean a better outcome).
Time Frame
Through study completion, an average of 6 months
Title
Feedback about usability from health care staff
Description
To obtain information from health professionals about usability of the VR set-up deployed, the System Usability Scale (SUS) was filled in by operators who participated during the VR sessions. The administration was performed after the administration of the experimental procedure. The SUS consists of a 10 item questionnaire on a 5-points Likert scale (1: Strongly agree; 5: Strongly disagree). The score for each question is converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores mean a better outcome.
Time Frame
Through study completion, an average of 6 months
Title
Feedback about acceptability from health care staff
Description
To obtain information from health professionals about acceptability, at the end of the experimental phase, a focus group was conducted with the health professionals that assisted users during the VR experience. Issues discussed during the focus group were the strengths and weaknesses associated with using virtual reality, the future perspectives, and the risks associated with using virtual reality with users affected by cognitive impairment.
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Pardini, PsyD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caterina Novara, PhD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Padova
City
Padova
State/Province
PD
ZIP/Postal Code
35131
Country
Italy
Facility Name
Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli"
City
Trento
State/Province
TN
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

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