Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT04442594
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2020-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Study Overview
Official Title:
REMINISCENCES : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMINISCENCES
Brief Summary:
Presentation \& Pre-screening of the control group / reminiscence group Patient/resident pre-screening team meeting for the study Explanation and proposal of the study to patients and their families Signature of resident/patient and family consents Audit of inclusion and non-inclusion criteria Inclusion Medical advice for VR Clinical interview with the family or legal guardian for an accurate life history + an anamnesis interview (psychologist or doctor) with the patient or resident.
Creation of video contents Creation of personalized video contents Clinical scales review Evaluation of the number of psychotropic molecules prescribed (coordinating doctor, general practitioner, geriatrician)
* Pre-test phase with the patient for the use of the VR headset
* Randomisation
* Session procedure As previously mentioned, the virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks.
Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).
The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.
The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.) with a different virtual environment every 3 weeks.
During the session, note will be taken on the subject's speech. The session will also be filmed and/or recorded with a prior signed agreement by the patient or his representative.
\- Last session (S6) Review of clinical scales (re-testing) Re-evaluation of drug prescriptions
Creation of video contents Creation of personalized video contents Clinical scales review Evaluation of the number of psychotropic molecules prescribed (coordinating doctor, general practitioner, geriatrician)
* Pre-test phase with the patient for the use of the VR headset
* Randomisation
* Session procedure As previously mentioned, the virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks.
Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).
The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.
The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.) with a different virtual environment every 3 weeks.
During the session, note will be taken on the subject's speech. The session will also be filmed and/or recorded with a prior signed agreement by the patient or his representative.
\- Last session (S6) Review of clinical scales (re-testing) Re-evaluation of drug prescriptions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: