Mental HealthNCT06917456
Novel VR Intervention for Use in Psychiatric Inpatient Wards
An observational study of Mental Health and Virtual Reality, run by South West London and St George's Mental Health NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Virtual Reality
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jul 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population in the study will include inpatients and staff from psychiatric inpatient wards.
Who may be able to join
- Current inpatient or staff member on an inpatient psychiatric ward
- Capacity to consent
Who cannot join
- Lacking capacity to provide consent
- History of seizures
- Has a pacemaker
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Springfield University Hospital, South West London & St. George's Mental Health NHS Trust
London
About this study
Official title: The Codesign and Evaluation of a Novel Virtual Reality Intervention for Use in Psychiatric Inpatient Wards
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.
Read more
Stage Two- Pilot stage. The Pilot stage will be held in the sensory rooms of two inpatient psychiatric wards. The recruitment period will last four weeks. During the four-week period, participants will have the option of attending a drop-in session held on their ward. The drop-in session will be held twice weekly for the four-week period and participants will be able to use the VR headset during this time period. They will be able to attend the drop-in session as frequently as they would like over the four week period, meaning that they have the ability to attend up to eight drop-in sessions. The new app will be piloted on sixteen inpatients to see if it is deemed acceptable and feasible for use on inpatient wards. the first use of the headset, as well as after four sessions (or earlier if the participant decides to end involvement before they reach four sessions). If a participant attends all eight sessions, they will complete the questionnaires again after the eighth session. Additionally, participants will complete the CR Comment Card before and after each use of the VR headset. Participants will also complete a short qualitative interview after their last session. The interview will comprise of asking participants to provide any feedback they have on the VR, as well as understanding more about how they could see the VR implemented into a ward setting.
Staff members will be recruited to assist in the running of the VR drop-in sessions. Staff will also be asked to provide any feedback on the sessions and observations of the sessions through a diary. At the end of the recruitment window, staff will also be asked to complete a short interview asking about topics such as any changes in participants' behaviour after the VR, logistical challenges around patients using the headsets, how the equipment was looked after and maintained, locations used for the VR and demands on staff time for the rollout.
- Conditions
- Mental Health, Virtual Reality
- Being tested
- Virtual Reality Headset
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Participants will use either a Meta Quest VR device, or a Pico headset. Both of these devices are standard non-medical hardware items.
| Study group | Role | What they receive |
|---|---|---|
| Participants from inpatient wards | This cohort will include patients and staff from inpatient psychiatric wards. Receives: Device: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the virtual reality software
Acceptability of the virtual reality software will be measured through the feedback provided in the qualitative interviews with the participants.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start21 Jul 2025
- Primary completion23 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- South West London and St George's Mental Health NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aileen O'Brien, Principal investigator, South West London & St. George's Mental Health NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917456
- Sponsor's protocol ID
- OBRA1004
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Codesign and Evaluation of a Novel Virtual Reality Intervention for Use in Psychiatric Inpatient Wards
- ClinicalTrials.gov ID
- NCT06917456
- Acronym / sponsor ID
- OBRA1004
- Conditions
- Mental Health, Virtual Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- South West London and St George's Mental Health NHS TrustUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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- Pilot stage. The Pilot stage will be held in the sensory rooms of two inpatient psychiatric wards. The recruitment period will last four weeks. During the four-week period, participants will have the option of attending a drop-in session held on their ward. The drop-in session will be held twice weekly for the four-week period and participants will be able to use the VR headset during this time period. They will be able to attend the drop-in session as frequently as they would like over the four week period, meaning that they have the ability to attend up to eight drop-in sessions. The new app will be piloted on sixteen inpatients to see if it is deemed acceptable and feasible for use on inpatient wards. the first use of the headset, as well as after four sessions (or earlier if the participant decides to end involvement before they reach four sessions). If a participant attends all eight sessions, they will complete the questionnaires again after the eighth session. Additionally, participants will complete the CR Comment Card before and after each use of the VR headset. Participants will also complete a short qualitative interview after their last session. The interview will comprise of asking participants to provide any feedback they have on the VR, as well as understanding more about how they could see the VR implemented into a ward setting.
Staff members will be recruited to assist in the running of the VR drop-in sessions. Staff will also be asked to provide any feedback on the sessions and observations of the sessions through a diary. At the end of the recruitment window, staff will also be asked to complete a short interview asking about topics such as any changes in participants' behaviour after the VR, logistical challenges around patients using the headsets, how the equipment was looked after and maintained, locations used for the VR and demands on staff time for the rollout.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants from inpatient wards | – | Device: Virtual Reality HeadsetThis cohort will include patients and staff from inpatient psychiatric wards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population in the study will include inpatients and staff from psychiatric inpatient wards.
Key inclusion criteria (2 listed)
- Current inpatient or staff member on an inpatient psychiatric ward
- Capacity to consent
Key exclusion criteria (3 listed)
- Lacking capacity to provide consent
- History of seizures
- Has a pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetParticipants will use either a Meta Quest VR device, or a Pico headset. Both of these devices are standard non-medical hardware items. | Device | Participants from inpatient wards |
Primary outcome
Acceptability of the virtual reality software
Time frame: through study completion, an average of 1 month
Acceptability of the virtual reality software will be measured through the feedback provided in the qualitative interviews with the participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aileen O'Brien principal investigator
South West London & St. George's Mental Health NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Virtual Reality, run by South West London and St George's Mental Health NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the virtual reality software (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.