The use of a new virtual reality software in psychiatric inpatient wards
| ISRCTN | ISRCTN53835117 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53835117 |
| ClinicalTrials.gov (NCT) | NCT06917456 |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 351569 |
| Protocol serial number | APP49548 |
| Sponsor | South West London and St George's Mental Health NHS Trust |
| Funders | Medical Research Council, Phase Space |
- Submission date
- 06/10/2025
- Registration date
- 10/11/2025
- Last edited
- 10/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The current study aims to examine the feasibility and acceptability of a virtual reality (VR) app for use on inpatient psychiatric wards. The study will be completed in two stages. Stage One is a co-design stage, and Stage Two is the Pilot stage.
Who can participate?
Adult staff who are currently working on an inpatient ward at Springfield University Hospital, and adult inpatients at Springfield University Hospital.
What does the study involve?
A VR hypnotherapy app that has been developed in collaboration with the company Phase Space will be trialled with psychiatric inpatients.
Stage One
Sixteen 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 VR headsets on the ward. The total feedback will be taken back to Phase Space, which will further modify the app to be implemented in the pilot stage.
Stage Two
The VR 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 VR 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 VR headset, as well as any additional feedback they have regarding the implementation of the headsets on inpatient wards.
What are the possible benefits and risks of participating?
There are no guaranteed benefits to taking part in the study. The use of the VR headset may provide participants with feelings of reduced stress. Study involvement also benefits the future of the study, as feedback will be used to develop the software further so it can possibly be implemented in clinical settings. All participants will also receive a gift voucher as a thank you for participation (£20 for Stage One, £30 for Stage Two).
It is not anticipated that any significant risks will be involved in the study. It is possible to feel cybersickness when using a VR headset. If this occurs, participants can take off the headset to let the symptoms subside. Participants can also withdraw involvement in the study at any point. It is not anticipated that participants will feel distressed due to study involvement, but if they do, the researchers can alert their care team and participants. If there are any technological problems with the VR headset, the researcher present will be trained to work through the problems.
Where is the study run from?
Springfield University Hospital, UK.
When is the study starting and how long is it expected to run for?
February 2025 to January 2026
Who is funding the study?
1. Medical Research Council (MRC), UK
2. Phase Space Ltd, UK
Who is the main contact?
Megan Cartier, megan.cartier@swlstg.nhs.uk
Contact information
Scientific, Principal investigator
South West London and St George's Mental Health NHS Trust
15 Springfield Drive
London
SW17 0YF
United Kingdom
| Phone | +44 (0)2035136491 |
|---|---|
| aileen.o'brien@swlstg.nhs.uk |
Public
15 Springfield Drive
London
SW17 0YF
United Kingdom
| Phone | +44 (0)7933172185 |
|---|---|
| megan.cartier@swlstg.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-site interventional pilot study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | The codesign and evaluation of a novel virtual reality intervention for use in psychiatric inpatient wards |
| Study objectives | Stage One: Gain feedback and reactions of patients and staff on the use of the VR headset to refine the VR content and provide input on the design of the Pilot Stage Two: Explore the feasibility of the use of VR in inpatient wards |
| Ethics approval(s) |
Approved 16/07/2025, East of England - Cambridge Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048285; cambridgecentral.rec@hra.nhs.uk), ref: 25/EE/0097 |
| Health condition(s) or problem(s) studied | Mental health conditions |
| Intervention | This study examines the use of a virtual reality headset for mental health conditions. There is no randomisation plan for the study as all participants will test out the virtual reality headset. They will use the headset to watch a seven-minute immersive experience, aimed at helping with feelings of stress and aiding in relaxation. Participants receive information on the programme before use and are aided in the use of the headset by two trained researchers. The study of the headset will be done in-person within the wards within the sensory or calm rooms, so participants have a quiet space to try out the headset. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Virtual reality hypnotherapy app and headset |
| Primary outcome measure(s) |
1. Stage One: Gather feedback and reactions of both staff and patients on the use of the VR headset to refine the content and provide input on the design of the Pilot, measured using qualitative interviews with patients and staff at the end of study involvement |
| Key secondary outcome measure(s) |
1. Stage One: Produce an implementation model to be tested in a Pilot, identify any areas requiring further modification, learn how to prepare staff and patients for the VR experience, identify the best location for the VR experience, and understand the practicalities of the headsets, measured using qualitative interviews with staff and patients at the end of study involvement |
| Completion date | 31/01/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 43 |
| Key inclusion criteria | Staff: 1. Currently working on an inpatient ward at Springfield University Hospital 2. Able to provide informed consent Patients: 1. Aged 18-65 years old 2. Current inpatient at Springfield University Hospital 3. Able to provide informed consent |
| Key exclusion criteria | Staff: 1. Not currently working on an inpatient ward at Springfield University Hospital 2.Unable to provide informed consent Patients: 1. Unable to provide informed consent 2. Has a history of seizures 3. Has a pacemaker |
| Date of first enrolment | 13/08/2025 |
| Date of final enrolment | 31/01/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Trinity Building
15 Springfield Drive
London
SW17 0YF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to current ethical approval. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/10/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
