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Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)

Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04365829
Acronym
RAVI
Enrollment
33
Registered
2020-04-28
Start date
2021-07-07
Completion date
2022-05-15
Last updated
2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Residents of Retirement Home (EHPAD)

Keywords

Residents of Retirement Home (EHPAD), Virtual reality, anxiety disorders

Brief summary

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).

Detailed description

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.

Interventions

DEVICEvirtual 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.

Sponsors

Gérond'if
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Assess the tolerance of the virtual environment according Simulator sickness questionnaire5 days

Secondary

MeasureTime frameDescription
Assessment of the trait and the state of anxiety according a psychological inventory State-Trait Anxiety Inventory scale (STAI-Y)5 DaysThe 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.
Measuring current mental wellbeing according World Health Organisation- Five Well-Being Index (WHO-5)5 DaysThe 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.
Measuring Heart Rate according the tensiometer5 Days
Measuring Blood Pressure according the tensiometer5 Daysboth systolic and diastolic blood pressure will be measured
evaluation of the impression on the Virtual Reality (VR) experience, the emotions aroused by it the motivation to renew it according to Acceptability Questionnaire5 Days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026