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

January 11, 2023 updated by: Gérond'if
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • IIe-de-France
      • Villejuif, IIe-de-France, France, 94800
        • Geriatric Department, Paul Brousse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality
Device: 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the tolerance of the virtual environment according Simulator sickness questionnaire
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)
Time Frame: 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.
5 Days
Measuring current mental wellbeing according "World Health Organisation- Five Well-Being" Index (WHO-5)
Time Frame: 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.
5 Days
Measuring Heart Rate according the tensiometer
Time Frame: 5 Days
5 Days
Measuring Blood Pressure according the tensiometer
Time Frame: 5 Days
both systolic and diastolic blood pressure will be measured
5 Days
evaluation of the impression on the Virtual Reality (VR) experience, the emotions aroused by it the motivation to renew it according to "Acceptability Questionnaire"
Time Frame: 5 Days
5 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gérond'if

Investigators

  • Study Chair: Emmanuelle DURON, MD, Geriatric Department, Paul Brousse Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

February 2, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00377-32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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