Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 8:05 AM
Study NCT ID:
NCT06917456
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel VR Intervention for Use in Psychiatric Inpatient Wards
Sponsor:
South West London and St George's Mental Health NHS Trust
Organization:
Study Overview
Official Title:
The Codesign and Evaluation of a Novel Virtual Reality Intervention for Use in Psychiatric Inpatient Wards
Status:
RECRUITING
Status Verified Date:
2025-09
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 current study aims to examine the feasibility and acceptability of a VR app for use on inpatient psychiatric wards. The study will be completed in two stages.
Stage One is a co-design stage. A virtual reality hypnotherapy app that has been developed in collaboration with the company Phase Space, will be trialled with psychiatric inpatients. 16 patients and six staff members will be recruited at this stage. The first eight patients will test the headset and provide feedback. Based on this, the app will be modified by Phase Space and then trialled by an additional eight patients. Concurrently with the recruitment of the 16 patients, six staff members from the ward will be recruited to complete an interview about the feasibility and use of virtual reality headsets on the ward. The total feedback will be taken back to Phase Space who will further modify the app to then be implemented in the pilot stage.
Stage Two is the Pilot stage. The virtual reality app will be piloted on fifteen inpatient participants. The full design of the pilot stage will be driven by the feedback given in Stage one. Participants will complete baseline questionnaires before the use of the headset, which will then be repeated when they have finished trialling the software. The measures will include a demographics questionnaire, as well as questionnaires regarding stress and anxiety, as well as other psychiatric symptoms. Patient participants will also be asked to complete an interview after they have finished participation to provide feedback on the use of the virtual reality software. A semi-structured questionnaire will be completed with six staff participants, where they will be asked to report any observations they made regarding those who used the virtual reality headset, as well as any additional feedback they have regarding the implementation of the headsets on inpatient wards.
Stage One is a co-design stage. A virtual reality hypnotherapy app that has been developed in collaboration with the company Phase Space, will be trialled with psychiatric inpatients. 16 patients and six staff members will be recruited at this stage. The first eight patients will test the headset and provide feedback. Based on this, the app will be modified by Phase Space and then trialled by an additional eight patients. Concurrently with the recruitment of the 16 patients, six staff members from the ward will be recruited to complete an interview about the feasibility and use of virtual reality headsets on the ward. The total feedback will be taken back to Phase Space who will further modify the app to then be implemented in the pilot stage.
Stage Two is the Pilot stage. The virtual reality app will be piloted on fifteen inpatient participants. The full design of the pilot stage will be driven by the feedback given in Stage one. Participants will complete baseline questionnaires before the use of the headset, which will then be repeated when they have finished trialling the software. The measures will include a demographics questionnaire, as well as questionnaires regarding stress and anxiety, as well as other psychiatric symptoms. Patient participants will also be asked to complete an interview after they have finished participation to provide feedback on the use of the virtual reality software. A semi-structured questionnaire will be completed with six staff participants, where they will be asked to report any observations they made regarding those who used the virtual reality headset, as well as any additional feedback they have regarding the implementation of the headsets on inpatient wards.
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?: