Clinical trial NCT04365829: Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
Official title: Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Residents of Retirement Home (EHPAD)
Keywords: Residents of Retirement Home (EHPAD)
Virtual reality
anxiety disorders
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 33
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess the tolerance of the virtual environment according Simulator sickness questionnaire
timeFrame: 5 days
Secondary outcomes:
measure: Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)
timeFrame: 5 Days
measure: Measuring current mental wellbeing according "World Health Organisation- Five Well-Being" Index (WHO-5)
timeFrame: 5 Days
measure: Measuring Heart Rate according the tensiometer
timeFrame: 5 Days
measure: Measuring Blood Pressure according the tensiometer
timeFrame: 5 Days
measure: evaluation of the impression on the Virtual Reality (VR) experience, the emotions aroused by it the motivation to renew it according to "Acceptability Questionnaire"
timeFrame: 5 Days
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Geriatric Department, Paul Brousse Hospital
state: IIe-de-France
Study officials:
affiliation: Geriatric Department, Paul Brousse Hospital
name: Emmanuelle DURON, MD
role: STUDY_CHAIR
References: