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.
| Title: | 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. |
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| Authors: | Clemmensen L; VIRTU Research Group, Copenhagen Research Centre of Mental Health (CORE), Psychiatric Centre Copenhagen, Hellerup, Denmark lars.clemmensen@regionh.dk.; Jørgensen G; VIRTU Research Group, Copenhagen Research Centre of Mental Health (CORE), Psychiatric Centre Copenhagen, Hellerup, Denmark.; Gundersen KB; VIRTU Research Group, Copenhagen Research Centre of Mental Health (CORE), Psychiatric Centre Copenhagen, Hellerup, Denmark.; Smith LC; VIRTU Research Group, Copenhagen Research Centre of Mental Health (CORE), Psychiatric Centre Copenhagen, Hellerup, Denmark.; Midtgaard J; Centre for applied research in mental health care (CARMEN), Psychiatric Center Glostrup, Glostrup, Denmark.; Department of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.; Bouchard S; University of Quebec, Quebec City, Quebec, Canada.; Thomsen CP; Mental Health Center Glostrup, Copenhagen, Denmark.; Turgut L; Mental Health Center Glostrup, Copenhagen, Denmark.; Glenthoj LB; VIRTU Research Group, Copenhagen Research Centre of Mental Health (CORE), Psychiatric Centre Copenhagen, Hellerup, Denmark.; Department of Psychology, University of Copenhagen, Copenhagen, Denmark. |
| Source: | BMJ open [BMJ Open] 2023 Sep 22; Vol. 13 (9), pp. e070566. Date of Electronic Publication: 2023 Sep 22. |
| Publication Type: | Journal Article; Clinical Trial Protocol |
| Language: | English |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| MeSH Terms: | Coercion* ; Patient Satisfaction*; Humans ; Behavior Observation Techniques ; Intensive Care Units ; Leisure Activities ; Pilot Projects ; Clinical Trials as Topic |
| Abstract: | Introduction: The environment at a psychiatric inpatient ward can lead to emotional distress and behavioural 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 recommended. The tested interventions have, however, shown varying effects and demand a high degree of planning and staff involvement while being difficult to adapt to individual needs. Virtual reality (VR) may help overcome these challenges.; Methods and Analysis: The study is a mixed-methods clinical trial with a target sample of 124 patients hospitalised at a closed psychiatric ward in the capital region of Denmark. Outcomes (eg, coercion, need-based medication and perceived stress) for a 12-month period where all patients are offered VR-based recreational experiences during their hospitalisation will be compared with outcomes for a 12-month period where VR is not offered. Feasibility and acceptability will be explored with qualitative interviews supplemented with non-participant observations and focus groups. The study began on 1 January 2023, and we expect to complete data collection by 31 December 2024.; Ethics and Dissemination: The study is registered at Danish Data Protection Agency (j.no P-2022-466) and is approved by the Committee on Health Research Ethics of the capital region of Denmark (j.no 22013313). All patients will be required to provide informed consent. Results from this study will be disseminated via peer-reviewed journals and congress/consortium presentations.; Trial Registration Number: NCT05654740.; (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Competing Interests: | Competing interests: SB is president and part owner of In Virtuo, a company that distributes virtual environments (although not those used in the current study), and conflict of interests are managed under UQO’s conflict of interest policy. No other authors declare competing interests. |
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| Contributed Indexing: | Keywords: Adult psychiatry; Anxiety disorders; PSYCHIATRY; Schizophrenia & psychotic disorders |
| Molecular Sequence: | ClinicalTrials.gov NCT05654740 |
| Entry Date(s): | Date Created: 20230922 Date Completed: 20230929 Latest Revision: 20260109 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC10533807 |
| DOI: | 10.1136/bmjopen-2022-070566 |
| PMID: | 37739476 |
| Database: | MEDLINE |
Journal Article; Clinical Trial Protocol