Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD) (RAVI)
Primary Purpose
Anxiety Disorders, Residents of Retirement Home (EHPAD)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
virtual reality headset "Occulus GO"
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety Disorders focused on measuring Residents of Retirement Home (EHPAD), Virtual reality, anxiety disorders
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.
Sites / Locations
- Geriatric Department, Paul Brousse Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality
Arm Description
Outcomes
Primary Outcome Measures
Assess the tolerance of the virtual environment according Simulator sickness questionnaire
Secondary Outcome Measures
Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)
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 current mental wellbeing according "World Health Organisation- Five Well-Being" Index (WHO-5)
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.
Measuring Heart Rate according the tensiometer
Measuring Blood Pressure according the tensiometer
both 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 Questionnaire"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04365829
Brief Title
Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
Acronym
RAVI
Official Title
Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gérond'if
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Residents of Retirement Home (EHPAD)
Keywords
Residents of Retirement Home (EHPAD), Virtual reality, anxiety disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
virtual reality headset "Occulus GO"
Intervention Description
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".
Primary Outcome Measure Information:
Title
Assess the tolerance of the virtual environment according Simulator sickness questionnaire
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)
Description
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.
Time Frame
5 Days
Title
Measuring current mental wellbeing according "World Health Organisation- Five Well-Being" Index (WHO-5)
Description
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.
Time Frame
5 Days
Title
Measuring Heart Rate according the tensiometer
Time Frame
5 Days
Title
Measuring Blood Pressure according the tensiometer
Description
both systolic and diastolic blood pressure will be measured
Time Frame
5 Days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle DURON, MD
Organizational Affiliation
Geriatric Department, Paul Brousse Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Geriatric Department, Paul Brousse Hospital
City
Villejuif
State/Province
IIe-de-France
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
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Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
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