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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality experiences | Experimental | Virtual Reality experiences are offered regularly |
|
| No Virtual Reality | No Intervention | Virtual Reality experiences are not offered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Experiences | Device | Virtual Reality experiences including stress reduction, distraction and entertainment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | ≥80% of the in-patients' consent to participating in the study | up to 26 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Global perceived level of stress over the past week | Measured by the Perceived Stress Scale, assessing the degree to which situations are appraised as stressful. | up to 26 weeks |
| Distress before and after using Virtual Reality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Clemmensen, PhD | Contact | 23492490 | lars.clemmensen@regionh.dk | |
| Louise B Glenthøj, PhD | Contact | Louise.Birkedal.Glenthoej@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lars Clemmensen, PhD | Psykiatrisk Center København | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Centre Copenhagen | Recruiting | Copenhagen | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37739476 | Derived | Clemmensen L, Jorgensen G, Gundersen KB, Smith LC, Midtgaard J, Bouchard S, Thomsen CP, Turgut L, Glenthoj LB. Study protocol for virtual leisure investigating the effect of virtual reality-delivered stress reduction, entertainment and distraction on the use of coercion and need-based medication and patient satisfaction at a closed psychiatric intensive care unit - a mixed-methods pilot clinical trial. BMJ Open. 2023 Sep 22;13(9):e070566. doi: 10.1136/bmjopen-2022-070566. |
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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.
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| 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 |
Measured by the Subjective Units of Distress Scale (SUDS) which measures the intensity of feelings and other internal experiences, such as anxiety, anger, agitation, stress or other painful feelings.
| up to 26 weeks |
| Number of days hospitalized. | up to 26 weeks |
| Risk of violence within the next 24 hours | Measured three times a day with the Brøset Violence Checklist (BVC) as part of standard procedure. | up to 26 weeks |