Anxiety Disorders Clinical Trial
— RAVIOfficial title:
Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
Verified date | January 2023 |
Source | Gérond'if |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 33 |
Est. completion date | May 15, 2022 |
Est. primary completion date | February 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria: - Mini Mental State Examination (M.M.S.E) scale = 20. - University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale = 12/20. - Living in Retirment Homes (EHPAD). - Good understanding of the French language. - Benefiting from a social security scheme. - Have read the newsletter and have consented to participate in the study by signing a written consent. Exclusion Criteria: - History of epileptic seizures. - Taking antihypertensive, neuroleptic, tricyclic antidepressants or parkinsonian drugs - Psychiatric disorders (Schizophrenia, dissociative disorders, borderline states, paranoia). - Hypertension (unless it is stabilized due to the absence of a change in antihypertensive treatment in the last 3 months and without a notable episode of orthostatic hypotension reported). - Vestibular or cerebellar syndromes. - Subjects under legal protection (curatorship, tutorship and safeguard of justice). - Refusal to participate. |
Country | Name | City | State |
---|---|---|---|
France | Geriatric Department, Paul Brousse Hospital | Villejuif | IIe-de-France |
Lead Sponsor | Collaborator |
---|---|
Gérond'if |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the tolerance of the virtual environment according Simulator sickness questionnaire | 5 days | ||
Secondary | 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. | 5 Days | |
Secondary | 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. | 5 Days | |
Secondary | Measuring Heart Rate according the tensiometer | 5 Days | ||
Secondary | Measuring Blood Pressure according the tensiometer | both systolic and diastolic blood pressure will be measured | 5 Days | |
Secondary | evaluation of the impression on the Virtual Reality (VR) experience, the emotions aroused by it the motivation to renew it according to "Acceptability Questionnaire" | 5 Days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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