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

NCT ID: NCT04365829

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2022-05-15

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.

Conditions

Anxiety Disorders; Residents of Retirement Home (EHPAD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual reality

Group Type: EXPERIMENTAL

virtual reality headset "Occulus GO"

Intervention Type: DEVICE

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".

Interventions

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".

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle DURON, MD

Role: STUDY_CHAIR

Geriatric Department, Paul Brousse Hospital

Locations

Geriatric Department, Paul Brousse Hospital

Villejuif, IIe-de-France, France

Countries

France

Other Identifiers

2020-A00377-32

Identifier Type: -

Identifier Source: org_study_id