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

G

Gérond'if

Status

Completed

Conditions

Residents of Retirement Home (EHPAD)
Anxiety Disorders

Treatments

Device: virtual reality headset "Occulus GO"

Study type

Interventional

Funder types

Other

Identifiers

NCT04365829
2020-A00377-32

Details and patient eligibility

About

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).

Full 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.

Enrollment

33 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Virtual reality
Experimental group
Treatment:
Device: virtual reality headset "Occulus GO"

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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