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Completed

NCT Number: NCT04365829

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

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).

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Key information

Conditions

Anxiety Disorders Mental Disorders Residents of Retirement Home (EHPAD)

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Department, Paul Brousse Hospital

Villejuif, IIe-de-France, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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".

Primary outcomes

  1. Assess the tolerance of the virtual environment according Simulator sickness questionnaire

    Time frame: 5 days

Secondary outcomes

  1. 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.

  2. 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.

  3. Measuring Heart Rate according the tensiometer

    Time frame: 5 Days

  4. Measuring Blood Pressure according the tensiometer

    Time frame: 5 Days

    both systolic and diastolic blood pressure will be measured

  5. 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

Sponsors and collaborators

Lead sponsor

Gérond'if

Other

Registry information

Acronym: RAVI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2020
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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