Anxiety DisordersRAVINCT04365829
Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
A study testing virtual reality headset "Occulus GO" in people with Anxiety Disorders and Residents of Retirement Home (EHPAD), run by Gérond'if at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Anxiety Disorders, Residents of Retirement Home (EHPAD)
- What is being tested?
- virtual reality headset "Occulus GO"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Geriatric Department, Paul Brousse Hospital
Villejuif, IIe-de-France, 94800
About this study
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).
Read the 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.
- Being tested
- virtual reality headset "Occulus GO"
- Keywords
- Residents of Retirement Home (EHPAD), Virtual reality, anxiety disorders
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality headset "Occulus GO"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".
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Not described Receives: Device: virtual reality headset "Occulus GO" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the tolerance of the virtual environment according Simulator sickness questionnaire
Measured: 5 days
Secondary outcomes (5)
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.
Measured: 5 Days
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.
Measured: 5 Days
Measuring Heart Rate according the tensiometer
Measured: 5 Days
Measuring Blood Pressure according the tensiometer
both systolic and diastolic blood pressure will be measured
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"
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start7 Jul 2021
- Primary completion2 Feb 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle DURON, MD, Study chair, Geriatric Department, Paul Brousse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365829
- Sponsor's protocol ID
- 2020-A00377-32
- Acronym
- RAVI
- Status last verified
- Jan 2023
- First submitted
- 23 Apr 2020
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)
- ClinicalTrials.gov ID
- NCT04365829
- Acronym / sponsor ID
- RAVI / 2020-A00377-32
- Keywords
- Residents of Retirement Home (EHPAD), Virtual reality, anxiety disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: virtual reality headset "Occulus GO" |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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". | Device | Virtual reality |
Primary outcome
Assess the tolerance of the virtual environment according Simulator sickness questionnaire
Time frame: 5 days
5 secondary outcomes
Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)
Time frame: 5 Days
Measuring current mental wellbeing according "World Health Organisation- Five Well-Being" Index (WHO-5)
Time frame: 5 Days
Measuring Heart Rate according the tensiometer
Time frame: 5 Days
Measuring Blood Pressure according the tensiometer
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Related trials for Anxiety Disorders
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
Anxiety
Not yet recruiting
Music for Reducing Anxiety Before Surgery
Preoperative Anxiety
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle DURON, MD study chair
Geriatric Department, Paul Brousse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality headset "Occulus GO" in people with Anxiety Disorders and Residents of Retirement Home (EHPAD), run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the tolerance of the virtual environment according Simulator sickness questionnaire (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.