Psychiatric HospitalizationNCT05654740
Virtual Leisure - Virtual Reality Delivered Recreation at a Closed Psychiatric Ward
A study testing Virtual Reality Experiences in people with Psychiatric Hospitalization, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psychiatric Hospitalization
- What is being tested?
- Virtual Reality Experiences
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to a closed psychiatric ward
- Ability to give informed consent
Who cannot join
- Significantly impaired vision hindering engagement in Virtual Reality experiences
Trial locations and contacts
1 site in 1 country.
Louise B Glenthøj, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre Copenhagen
Copenhagen, 2600
About this study
Official title: 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.
- Conditions
- Psychiatric Hospitalization
- Being tested
- Virtual Reality Experiences
- Keywords
- Psychiatric in-patient care, Virtual Reality, Coercion, Stress reduction, Entertainment, Distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ExperiencesDevice
Virtual Reality experiences including stress reduction, distraction and entertainment
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality experiences | Experimental | Virtual Reality experiences are offered regularly Receives: Device: Virtual Reality Experiences |
| No Virtual Reality | No intervention | Virtual Reality experiences are not offered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
≥80% of the in-patients' consent to participating in the study
Measured: up to 26 weeks
Secondary outcomes (3)
Need-based medication
Use of need-based medication (e.g. benzodiazepines and antipsychotic medication)
Measured: up to 26 weeks
Client Satisfaction
The Client Satisfaction Questionnaire will be used to assess patients satisfaction with treatment.
Measured: 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)
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychiatric HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Clemmensen, PhD, Principal investigator, Psykiatrisk Center København
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654740
- Sponsor's protocol ID
- 1000
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasmussen K, Arnfred BAT, Jorgensen G, Clemmensen L, Turgut L, Thomsen CP, Midtgaard J, Glenthoj LB. Use of recreational virtual reality for stress reduction in a psychiatric intensive care unit: findings from a mixed-methods pilot clinical trial. BMJ Open. 2026 Jul 23;16(7):e114385. doi: 10.1136/bmjopen-2025-114385.
PubMed 42493203Clemmensen 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.
PubMed 37739476
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of the Virtual Leisure Pilot Study - Virtual Reality Delivered Stress Reduction, Entertainment, and Distraction at a Closed Psychiatric Ward
- ClinicalTrials.gov ID
- NCT05654740
- Acronym / sponsor ID
- 1000
- Conditions
- Psychiatric Hospitalization
- Keywords
- Psychiatric in-patient care, Virtual Reality, Coercion, Stress reduction, Entertainment, Distraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality experiences | Experimental | Device: Virtual Reality ExperiencesVirtual Reality experiences are offered regularly |
| No Virtual Reality | No intervention | –Virtual Reality experiences are not offered |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to a closed psychiatric ward
- Ability to give informed consent
Key exclusion criteria (1 listed)
- Significantly impaired vision hindering engagement in Virtual Reality experiences
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality ExperiencesVirtual Reality experiences including stress reduction, distraction and entertainment | Device | Virtual Reality experiences |
Primary outcome
Acceptability
Time frame: up to 26 weeks
≥80% of the in-patients' consent to participating in the study
3 secondary outcomes
Need-based medication
Time frame: up to 26 weeks
Client Satisfaction
Time frame: up to 26 weeks
Coercive actions
Time frame: up to 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 42493203Rasmussen K, Arnfred BAT, Jorgensen G, Clemmensen L, Turgut L, Thomsen CP, Midtgaard J, Glenthoj LB. Use of recreational virtual reality for stress reduction in a psychiatric intensive care unit: findings from a mixed-methods pilot clinical trial. BMJ Open. 2026 Jul 23;16(7):e114385. doi: 10.1136/bmjopen-2025-114385.
- Derived from this study: PubMed 37739476Clemmensen 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.
- Individual participant dataSharing planned: No
Related trials for Psychiatric Hospitalization
Enrolling by invitation
Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
Insomnia, Depression
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Recruiting
A Brief Case Management Intervention to Promote Personal Recovery and Prevent Psychiatric Involuntary Readmissions.
Psychiatric Disorder, Involuntary Psychiatric Hospitalization
Not yet recruitingObservational study
Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness
Severe Mental Illness, Hospitalizations Psychiatric
RecruitingObservational study
Psychosocial Factors in Dual Diagnosis in a General Hospital
Dual Diagnosis, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise B Glenthøj, PhD contact
Lars Clemmensen, PhD principal investigator
Psykiatrisk Center København
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Experiences in people with Psychiatric Hospitalization, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Clemmensen, PhD (23492490, lars.clemmensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.