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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Hospitalization
• Intervention / Treatment: Device: Virtual Reality Experiences

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Clemmensen, PhD; Phone Number: 23492490; Email: lars.clemmensen@regionh.dk
• Study Contact Backup: Name: Louise B Glenthøj, PhD; Email: Louise.Birkedal.Glenthoej@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2600
    • Recruiting
    • Mental Health Centre Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality experiences; Virtual Reality experiences are offered regularly	Device: Virtual Reality Experiences; Virtual Reality experiences including stress reduction, distraction and entertainment
No Intervention: No Virtual Reality; Virtual Reality experiences are not offered

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Investigators: Principal Investigator: Lars Clemmensen, PhD, Psykiatrisk Center København

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Stress reduction; Distraction; Psychiatric in-patient care; Coercion; Entertainment
• Other Study ID Numbers: 1000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No