An interventional study of virtual reality headset "Occulus GO" in Anxiety Disorders and Residents of Retirement Home (EHPAD), sponsored by Gérond'if. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by Gérond'if · Not applicable, Interventional, and Supportive care
The main purpose of this study is to assess the tolerance of the virtual environment in the elderly living in a nursing home (EHPAD). It will be evaluated by the cybersickness collection after each session (1 session every other day for a total of 3 sessions).
The purpose of this muliticentric, interventional, uncontrolled study is to assess the tolerance of the virtual environment in the elderly living in a nursing home
subjects who fulfil the inclusion criteria and after signing the informed consent will benefit from three individual virtual reality (VR) sessions.
The sessions will be performed out with one day apart
An assessment of anxiety trait and well-being of each subject will be performed before the first session (D1) and after the third (D3).
An assessment of anxiety as a condition will be performed before and after each session.
Heart rate and blood pressure measurements will be made before, during and after each session.
At the end of each session, an evaluation of cybersickness will be performed. Feedback on the acceptability of the experience will be provided at the end of each session.
Each session will last 1 hour in total: the person will visualize a single scene of virtual reality presenting a natural environment of a duration of 7 minutes preceded by a time of introduction, evaluation and followed by a time dedicated to evaluations and maintenance.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 33 is below the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Gérond'if is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: virtual reality headset "Occulus GO"
Use of a virtual reality headset for one week at a frequency of 3 days per week (D1, D3 and D5). During each session (1 hour), the subject will visualize a scene of natural virtual environment (a garden, animals in the wild, a grand Canyon) lasting 7 min using an virtual reality headset "Occulus GO".
Assess the tolerance of the virtual environment according Simulator sickness questionnaire
Time frame: 5 days
Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)
The State-Trait Anxiety Inventory (STAI-Y) is a psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety.
Time frame: 5 Days
Measuring current mental wellbeing according "World Health Organisation- Five Well-Being" Index (WHO-5)
The total score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Time frame: 5 Days
Measuring Heart Rate according the tensiometer
Time frame: 5 Days
Measuring Blood Pressure according the tensiometer
both systolic and diastolic blood pressure will be measured
Time frame: 5 Days
evaluation of the impression on the Virtual Reality (VR) experience, the emotions aroused by it the motivation to renew it according to "Acceptability Questionnaire"
Time frame: 5 Days
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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