Clinical Trials Directory

Trials / Completed

CompletedNCT04365829

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Gérond'if · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEvirtual 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".

Timeline

Start date
2021-07-07
Primary completion
2022-02-02
Completion
2022-05-15
First posted
2020-04-28
Last updated
2023-01-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04365829. Inclusion in this directory is not an endorsement.