Clinical trial NCT05654740: Virtual Leisure - Virtual Reality Delivered Recreation at a Closed Psychiatric Ward
Official title: Design of the Virtual Leisure Pilot Study - Virtual Reality Delivered Stress Reduction, Entertainment, and Distraction at a Closed Psychiatric Ward
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatric Hospitalization
Keywords: Psychiatric in-patient care
Virtual Reality
Coercion
Stress reduction
Entertainment
Distraction
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We will compare outcomes for a 12-month period where all patients are offered Virtual Reality experiences regularly to outcomes for a 12-month period with no availability of Virtual Reality experiences in one specified closed psychiatric ward.
Primary purpose: TREATMENT

Brief summary: Background: The environment at a psychiatric in-patient ward can lead to emotional distress and behavioral deviations in vulnerable individuals potentially resulting in conflicts, increased use of need-based medication and coercive actions, along with low satisfaction with treatment. To accommodate these challenges recreational and entertaining interventions are generally recommended. The tested interventions have, however, shown varying effects and often demand a high degree of planning and staff involvement while also being difficult to adapt to individual needs. Virtual Reality (VR) may help overcome these challenges.

Methods: The study is a clinical trial, employing a mixed-methods design, enrolling 124 patients hospitalized at one closed psychiatric ward in the capital region of Denmark. All patients will be offered VR based stress reduction (e.g., mindfulness/relaxation techniques), entertainment, and distraction regularly during their hospitalization. Feasibility and acceptability will be explored with qualitative interviews supplemented with repeated non-participants observations and focus groups. The effect of the intervention will be assessed by comparing quantitative outcomes (e.g., coercion, need-based medication, and perceived stress) for a 12-month period with VR experiences available to a 12-month period without VR experiences available.

Discussion: It is of significant interest to find non-intrusive interventions with minimal side-effects that may provide an alternative to pharmacological interventions and coercive actions in mental health services. If the VR intervention is found to be feasible and acceptable a larger study can be initiated and if found to be effective in a psychiatric in-patient setting, it can be scaled for use in psychiatric treatment facilities in general where it may benefit a large group of patients.


Eligibility criteria: Inclusion Criteria:

* Admitted to a closed psychiatric ward
* Ability to give informed consent

Exclusion Criteria:

* Significantly impaired vision hindering engagement in Virtual Reality experiences

Primary outcomes:
measure: Acceptability
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Need-based medication
timeFrame: up to 26 weeks
measure: Client Satisfaction
timeFrame: up to 26 weeks
measure: Coercive actions
timeFrame: up to 26 weeks
Other outcomes:
measure: Global perceived level of stress over the past week
timeFrame: up to 26 weeks
measure: Distress before and after using Virtual Reality
timeFrame: up to 26 weeks
measure: Number of days hospitalized.
timeFrame: up to 26 weeks
measure: Risk of violence within the next 24 hours
timeFrame: up to 26 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Centre Copenhagen
Study officials:
affiliation: Psykiatrisk Center København
name: Lars Clemmensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: