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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the virtual reality software', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Acceptability of the virtual reality software will be measured through the feedback provided in the qualitative interviews with the participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': '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.\n\nStage 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.\n\nStage 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population in the study will include inpatients and staff from psychiatric inpatient wards.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current inpatient or staff member on an inpatient psychiatric ward\n* Capacity to consent\n\nExclusion Criteria:\n\n* Lacking capacity to provide consent\n* History of seizures\n* Has a pacemaker'}, 'identificationModule': {'nctId': 'NCT06917456', 'briefTitle': 'Novel VR Intervention for Use in Psychiatric Inpatient Wards', 'organization': {'class': 'OTHER', 'fullName': "South West London and St George's Mental Health NHS Trust"}, 'officialTitle': 'The Codesign and Evaluation of a Novel Virtual Reality Intervention for Use in Psychiatric Inpatient Wards', 'orgStudyIdInfo': {'id': 'OBRA1004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants from inpatient wards', 'description': 'This cohort will include patients and staff from inpatient psychiatric wards.', 'interventionNames': ['Device: Virtual Reality Headset']}], 'interventions': [{'name': 'Virtual Reality Headset', 'type': 'DEVICE', 'description': 'Participants will use either a Meta Quest VR device, or a Pico headset. Both of these devices are standard non-medical hardware items.', 'armGroupLabels': ['Participants from inpatient wards']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': "Aileen O'Brien", 'role': 'CONTACT', 'email': "Aileen.O'Brien@swlstg.nhs.uk", 'phone': '+44 02035136491'}], 'facility': "Springfield University Hospital, South West London & St. George's Mental Health NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': "Aileen O'Brien", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "South West London & St. George's Mental Health NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "South West London and St George's Mental Health NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}