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

Psychiatric Hospitalization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654740
• Other study ID #: 1000
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Lars Clemmensen, PhD
• Phone: 23492490
• Email: lars.clemmensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Admitted to a closed psychiatric ward

• Ability to give informed consent

Exclusion Criteria:

• Significantly impaired vision hindering engagement in Virtual Reality experiences

Related Conditions & MeSH terms

• Psychiatric Hospitalization

Intervention

Device:
• Virtual Reality Experiences
Virtual Reality experiences including stress reduction, distraction and entertainment

Locations

Country	Name	City	State
Denmark	Mental Health Centre Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Distress before and after using Virtual Reality	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
Other	Number of days hospitalized.		up to 26 weeks
Other	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
Primary	Acceptability	=80% of the in-patients' consent to participating in the study	up to 26 weeks
Secondary	Need-based medication	Use of need-based medication (e.g. benzodiazepines and antipsychotic medication)	up to 26 weeks
Secondary	Client Satisfaction	The Client Satisfaction Questionnaire will be used to assess patients satisfaction with treatment.	up to 26 weeks
Secondary	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