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

Not Applicable

Recruiting

• Conditions: Psychiatric Hospitalization
• Interventions: Device: Virtual Reality Experiences

• Registration Number: NCT05654740
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-08
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Study Start: 2023-01-01
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

Exclusion Criteria

• Significantly impaired vision hindering engagement in Virtual Reality experiences

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Virtual Reality experiences	Virtual Reality Experiences	Virtual Reality experiences are offered regularly

Primary Outcome Measures

Name	Time	Method
Acceptability	up to 26 weeks	≥80% of the in-patients' consent to participating in the study

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction	up to 26 weeks	The Client Satisfaction Questionnaire will be used to assess patients satisfaction with treatment.
Need-based medication	up to 26 weeks	Use of need-based medication (e.g. benzodiazepines and antipsychotic medication)
Coercive actions	up to 26 weeks	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)

Trial Locations

Locations (1)

Mental Health Centre Copenhagen; 🇩🇰 Copenhagen, Denmark