Virtual Leisure - Virtual Reality Delivered Recreation at a Closed Psychiatric Ward

Study Overview
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Brief Summary
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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.

Official Title
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Design of the Virtual Leisure Pilot Study - Virtual Reality Delivered Stress Reduction, Entertainment, and Distraction at a Closed Psychiatric Ward

Conditions
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Psychiatric Hospitalization

Intervention / Treatment
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* Device: Virtual Reality Experiences


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to a closed psychiatric ward Ability to give informed consent Exclusion Criteria: Significantly impaired vision hindering engagement in Virtual Reality experiences

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality experiences<br>Virtual Reality experiences are offered regularly | Device: Virtual Reality Experiences<br>* Virtual Reality experiences including stress reduction, distraction and entertainment<br>|
| No Intervention: No Virtual Reality<br>Virtual Reality experiences are not offered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | ≥80% of the in-patients' consent to participating in the study | up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need-based medication | Use of need-based medication (e.g. benzodiazepines and antipsychotic medication) | up to 26 weeks | 
| Client Satisfaction | The Client Satisfaction Questionnaire will be used to assess patients satisfaction with treatment. | up to 26 weeks | 
| Coercive actions | Coercive actions during patient's hospitalization and the closed psychiatric ward. Coercive actions comprise mechanical restraint (belt fixation) and forced sedation (injecting the patient with sedating medication without their consent to diminish aggressive behavior) | up to 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatric in-patient care, Virtual Reality, Coercion, Stress reduction, Entertainment, Distraction