NCT03647605

Pilot Study: VR Mind and VR Mind+ Intervention

Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tomorrow Sp. z o.o. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Social Phobia

Interventions

Type	Name	Description
BEHAVIORAL	VR Mind	Two VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety. The pilot study will consist of two scenarios: "Public Speaking in Lecture Hall" and "Telephoning in Public". Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes.

Timeline

• Start date: 2018-09-13
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-08-27
• Last updated: 2019-02-12

Locations

1 site across 1 country: Poland