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Cognitive ImpairmentNCT05863065

Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

A study testing Exposure to a Virtual Reality scenarios in people with Cognitive Impairment and Cognitive Decline, run by University of Padova at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Exposure to a Virtual Reality scenarios
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
2 sitesItaly
Study dates
23 Jan 2023to 6 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • University of Padova

    Padova, PD, 35131

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

    Trento, TN

Other trials in Italy

About this study

Official title: Personalized Virtual Reality Naturalistic Scenarios Promoting Engagement and Relaxation in Patients With Cognitive Impairment: a Proof-of-concept Mixed-methods Study

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).

Read the 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.
Being tested
Exposure to a Virtual Reality scenarios
Keywords
virtual reality, personalized virtual scenario, user centered approach, mixed-methods study, user-experience, feasibility study, relaxation, anxiety
Medical subject headings
Cognitive Dysfunction, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure to a Virtual Reality scenariosOther

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

Study groups in NCT05863065
Study groupRoleWhat they receive
Personalized Virtual Reality exposureExperimentalParticipants are exposed to a personalized, relaxing VR scenario administered by the Oculus Quest 2 tool.
Receives: Other: Exposure to a Virtual Reality scenarios

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 6 months

  2. 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.

    Measured: Through study completion, an average of 6 months

  3. 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.

    Measured: Through study completion, an average of 6 months

Secondary outcomes (5)

  1. 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.

    Measured: Through study completion, an average of 6 months

  2. 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").

    Measured: Through study completion, an average of 6 months

  3. 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).

    Measured: Through study completion, an average of 6 months

  4. 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.

    Measured: Through study completion, an average of 6 months

  5. 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.

    Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start23 Jan 2023
  3. Primary completion6 Mar 2023
  4. Study completion6 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05863065
Sponsor's protocol ID
VR2022
Status last verified
May 2023
First submitted
28 Apr 2023
Last updated
17 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37993549

Questions about this trial

What is this clinical trial studying?

A study testing Exposure to a Virtual Reality scenarios in people with Cognitive Impairment and Cognitive Decline, run by University of Padova at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment. (time frame: Through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05863065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

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