NCT06917456

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- 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 21, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 18, 2025

Last Update Submit

March 31, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 1 month

Study Arms (1)

Participants from inpatient wards

This cohort will include patients and staff from inpatient psychiatric wards.

Device: Virtual Reality Headset

Interventions

Participants will use either a Meta Quest VR device, or a Pico headset. Both of these devices are standard non-medical hardware items.

Participants from inpatient wards

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population in the study will include inpatients and staff from psychiatric inpatient wards.

You may qualify if:

  • Current inpatient or staff member on an inpatient psychiatric ward
  • Capacity to consent

You may not qualify if:

  • Lacking capacity to provide consent
  • History of seizures
  • Has a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Springfield University Hospital, South West London & St. George's Mental Health NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Aileen O'Brien

    South West London & St. George's Mental Health NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

April 8, 2025

Study Start

July 21, 2025

Primary Completion

February 23, 2026

Study Completion

March 31, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations