Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-04 @ 10:50 PM
Study NCT ID:
NCT03647605
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study: VR Mind and VR Mind+ Intervention
Sponsor:
Tomorrow Sp. z o.o.
Organization:
Study Overview
Official Title:
Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention
Status:
COMPLETED
Status Verified Date:
2019-01
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:
None
Brief Summary:
The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be:
* the length of the laboratory session utilizing virtual reality exposure (feasibility),
* the ergonomics and ease of use for both patients and system operators (usability),
* the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety).
The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.
* the length of the laboratory session utilizing virtual reality exposure (feasibility),
* the ergonomics and ease of use for both patients and system operators (usability),
* the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety).
The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.
Detailed Description:
In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The pilot investigators will be tested for the feasibility, usability and safety of the system in order to obtain information useful in further designs for the clinical trial. The research consists of four laboratory sessions. The first and the last session will be dedicated to participant assessment. During the second and third session the virtual reality scenarios (2 x 10 minutes for each session) will be presented to participants. The participants will be playing a role of someone who is giving a speech (Public speaking scenario) and someone who is speaking on a phone in public (Telephoning in public scenario).
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?: