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

NCT05654740 | Unknown DMC

• 1 other identifier: 1000
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

Psychiatric in-patient care; Virtual Reality; Coercion; Stress reduction; Entertainment; Distraction

Outcome Measures

Primary Outcomes (1)

• Acceptability

  ≥80% of the in-patients' consent to participating in the study

  up to 26 weeks

Secondary Outcomes (3)

• Need-based medication

  up to 26 weeks

• Client Satisfaction

  up to 26 weeks

• Coercive actions

  up to 26 weeks

Other Outcomes (4)

• Global perceived level of stress over the past week

  up to 26 weeks

• Distress before and after using Virtual Reality

  up to 26 weeks

• Number of days hospitalized.

  up to 26 weeks

Study Arms (2)

Virtual Reality experiences

EXPERIMENTAL

Virtual Reality experiences are offered regularly

Device: Virtual Reality Experiences

No Virtual Reality

NO INTERVENTION

Virtual Reality experiences are not offered

Interventions

Virtual Reality Experiences DEVICE

Virtual Reality experiences including stress reduction, distraction and entertainment

Virtual Reality experiences

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significantly impaired vision hindering engagement in Virtual Reality experiences

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, 2600, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 37739476 DERIVED

Study Officials

• Lars Clemmensen, PhD

  Psykiatrisk Center København

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Clemmensen, PhD

CONTACT

23492490; lars.clemmensen@regionh.dk

Louise B Glenthøj, PhD

CONTACT

Louise.Birkedal.Glenthoej@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 16, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)