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

NCT ID: NCT05654740

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Psychiatric Hospitalization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality experiences

Virtual Reality experiences are offered regularly

Group Type: EXPERIMENTAL

Virtual Reality Experiences

Intervention Type: DEVICE

Virtual Reality experiences including stress reduction, distraction and entertainment

No Virtual Reality

Virtual Reality experiences are not offered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Experiences

Virtual Reality experiences including stress reduction, distraction and entertainment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Significantly impaired vision hindering engagement in Virtual Reality experiences

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Clemmensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Psykiatrisk Center København

Locations

Mental Health Centre Copenhagen

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Lars Clemmensen, PhD

Role: CONTACT

lars.clemmensen@regionh.dk

23492490

Louise B Glenthøj, PhD

Role: CONTACT

Louise.Birkedal.Glenthoej@regionh.dk

References

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.

Reference Type: DERIVED

PMID: 37739476 (View on PubMed)

Other Identifiers

1000

Identifier Type: -

Identifier Source: org_study_id