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

Not Applicable

Completed

• Conditions: Anxiety Disorders; Residents of Retirement Home (EHPAD)
• Interventions: Device: virtual reality headset "Occulus GO"

• Registration Number: NCT04365829
• Lead Sponsor: Gérond'if

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.

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Study Start: 2021-07-07
• Primary Completion: 2022-02-02
• Study Completion: 2022-05-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality	virtual reality headset "Occulus GO"	-

Primary Outcome Measures

Name	Time	Method
Assess the tolerance of the virtual environment according Simulator sickness questionnaire	5 days

Secondary Outcome Measures

Name	Time	Method
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
Measuring Blood Pressure according the tensiometer	5 Days	both systolic and diastolic blood pressure will be measured
Measuring current mental wellbeing according "World Health Organisation- Five Well-Being" Index (WHO-5)	5 Days	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.
Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)	5 Days	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.
Measuring Heart Rate according the tensiometer	5 Days

Trial Locations

Locations (1)

Geriatric Department, Paul Brousse Hospital; 🇫🇷 Villejuif, IIe-de-France, France