Anxiety StateNCT03918954
Comparison of Physical and Virtual Sensory Room in an Inpatient Setting
A study testing Virtual sensory room and Sensory room in people with Anxiety State and Depression, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Sensory room is a new method in psychiatric inpatient care for management of anxiety. Since this method for anxiety management is being implemented more and more extensively within the psychiatric care system it is important to study its effect and whether there is any difference between physical and virtual sensory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety State, Depression, Bipolar Depression
- What is being tested?
- Virtual sensory room and Sensory room
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2019to 1 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to one of the two eligible inpatient units
- Age over 18 years
Who cannot join
- Diagnosis of schizophrenia (ICD-10 F20) or schizoaffective disorder (ICD-10 F25)
- Intellectual developmental disorder, organic brain injury or other condition that precludes informed consent
- Active withdrawal symptoms from alcohol or other substances of abuse
- Visual or balance disorder
Trial locations and contacts
1 site in 1 country.
About this study
Sensory room is a new method in psychiatric inpatient care for management of anxiety. Since this method for anxiety management is being implemented more and more extensively within the psychiatric care system it is important to study its effect and whether there is any difference between physical and virtual sensory.
In this study, the effect on mental well-being, pulse and blood pressure will be compared before and after each use of a virtual or physically sensory room. How the different methods affect the total care time, use of anxiety medication and results from self-assessment scales to measure depression and anxiety symptoms will also be looked at. The study will be conducted on two separate wards which primarily care for patients with the primary diagnosis of bipolar disorder.
Read the detailed description
This study will include about 100 research subjects admitted to an inpatient ward at the department of psychiatry for affective disorder. The study will be conducted in two inpatient wards. Patients who consent to participation will be offered to stay in a sensory room (a physical sensory room in one ward and a virtual sensory room via a pair of wireless VR glasses in another ward). In connection with the use of the virtual or physical sensory room, the patients will be given a visual analogue scale which asks the patient to rate their overall anxiety and mental health on a scale from 1 (feeling very bad) to 10 (feeling excellent). This will be the primary measure of the study. Before and after each visit the participant will have their pulse and blood pressure measured.
Included patients will also be asked about participation in individual interviews. Semi-structured interviews will be carried out and collected data will be analyzed with a phenomenological approach. The purpose of this study is to shed light on experiences of staying in the digital and analogue sensory rooms.
A number of self-rated questionnaires will be used in the project to establish the research subjects' level of depression and anxiety during their inpatient stay.
- The Montgomery-Åsberg Depression Rating (MADRS-S) scale. MADRS-S is a self-assessment tool for assessing depression symptoms, it is used regularly in the clinic to evaluate depression symptoms. The inventory consists of a self-assessment form containing 9 statements intended to measure different depression symptoms. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge.
- Beck Anxiety Inventory (BAI) is a self-assessment instrument that measures the degree of anxiety. The inventory consists of a self-assessment form containing 21 statements intended to measure 21 different anxiety symptoms. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge.
- The Clinical Global Impressions (CGI) scale. CGI is a 7-scaled evaluation tool that requires the physician to determine the degree of the patient's disease at the time of assessment, in relation to the clinician's previous experience in patients with the same diagnosis. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge.
- Conditions
- Anxiety State, Depression, Bipolar Depression
- Being tested
- Virtual sensory room, Sensory room
- Medical subject headings
- Anxiety Disorders, Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual sensory roomDevice
A pair of virtual reality glasses (Oculus Go) with installed the program Calm Place, a program designed for anxiety reduction.
Sensory roomOther
A room with calming elements that patients can use to feel calm.
| Study group | Role | What they receive |
|---|---|---|
| Physical sensory room | Active comparator | In the inpatient ward there is a specifically designed room for calming down which a patient can request access to. In the room there is calming music, soft mats, nature themed wallpaper and calming visual lighting. Receives: Other: Sensory room |
| Virtual sensory room | Experimental | The patients will have access to wireless virtual reality glasses during a session. The glasses will have a specially made protection that will be disinfected between each user, all users will also have the opportunity to choose a disposable cover for the glasses. The VR glasses are adjustable and adaptable to all types of head sizes and can be used with regular glasses. The application accessable in the VR glasses is called Calm Place, a virtual natural environment with day and night cycles, dynamic weather and associated soundscapes. Receives: Device: Virtual sensory room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Visual Analogue Scale of anxiety
A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety
Measured: Immediately before and following the first administration of treatment
Secondary outcomes (8)
Beck´s Anxiety Scale
Total score on 21 self-rated questions on anxiety (ranging from 0=no anxiety to 63=maximum level of anxiety)
Measured: Once weekly from date of inclusion until the date of discharge up to 3 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS-S)
Depression grade on a self-rating scale ranging from 0=no depression to 54=most severe depression
Measured: Once weekly from date of inclusion until the date of discharge up to 3 weeks
Use of anxiolytic medication
Use in mg of anxiolytic medication
Measured: Total use of medication from date of inclusion to date of discharge up to 3 weeks
Clinical Global Impression
Clinician assessment of patient´s overall mental state ranging from 0 (no symptoms) to 7 (severe mental illness)
Measured: Once weekly from date of inclusion until the date of discharge up to 3 weeks
Length of stay
Number of days admitted to inpatient care
Measured: Length of admission in days from date of inclusion to date of discharge up to a year
Blood pressure
mmHg before and after intervention
Measured: Immediately before and following first administration of treatment
Pulse
Heartbeats per minute before and after intervention
Measured: Immediately before and following first administration of treatment
Visual Analogue Scale of anxiety
A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety
Measured: An average of each immediate before and following measure of the administration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 May 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Stockholm University
- Responsible party
- Sponsor
- Investigators
- Steinn Steingrimsson, PhD, Study director, Sahlgrenska Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918954
- Sponsor's protocol ID
- VGRVR
- Status last verified
- Jun 2020
- First submitted
- 10 Jan 2019
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilioudi M, Lindner P, Ali L, Wallstrom S, Thunstrom AO, Ioannou M, Anving N, Johansson V, Hamilton W, Falk O, Steingrimsson S. Physical Versus Virtual Reality-Based Calm Rooms for Psychiatric Inpatients: Quasi-Randomized Trial. J Med Internet Res. 2023 May 19;25:e42365. doi: 10.2196/42365.
PubMed 37204858
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical and Virtual Sensory Room in an Inpatient Setting
- ClinicalTrials.gov ID
- NCT03918954
- Acronym / sponsor ID
- VGRVR
- Conditions
- Anxiety State, Depression, Bipolar Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Stockholm University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 18 Apr 2019 (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.
Sensory room is a new method in psychiatric inpatient care for management of anxiety. Since this method for anxiety management is being implemented more and more extensively within the psychiatric care system it is important to study its effect and whether there is any difference between physical and virtual sensory.
In this study, the effect on mental well-being, pulse and blood pressure will be compared before and after each use of a virtual or physically sensory room. How the different methods affect the total care time, use of anxiety medication and results from self-assessment scales to measure depression and anxiety symptoms will also be looked at. The study will be conducted on two separate wards which primarily care for patients with the primary diagnosis of bipolar disorder.
Detailed description
This study will include about 100 research subjects admitted to an inpatient ward at the department of psychiatry for affective disorder. The study will be conducted in two inpatient wards. Patients who consent to participation will be offered to stay in a sensory room (a physical sensory room in one ward and a virtual sensory room via a pair of wireless VR glasses in another ward). In connection with the use of the virtual or physical sensory room, the patients will be given a visual analogue scale which asks the patient to rate their overall anxiety and mental health on a scale from 1 (feeling very bad) to 10 (feeling excellent). This will be the primary measure of the study. Before and after each visit the participant will have their pulse and blood pressure measured.
Included patients will also be asked about participation in individual interviews. Semi-structured interviews will be carried out and collected data will be analyzed with a phenomenological approach. The purpose of this study is to shed light on experiences of staying in the digital and analogue sensory rooms.
A number of self-rated questionnaires will be used in the project to establish the research subjects' level of depression and anxiety during their inpatient stay.
- The Montgomery-Åsberg Depression Rating (MADRS-S) scale. MADRS-S is a self-assessment tool for assessing depression symptoms, it is used regularly in the clinic to evaluate depression symptoms. The inventory consists of a self-assessment form containing 9 statements intended to measure different depression symptoms. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge.
- Beck Anxiety Inventory (BAI) is a self-assessment instrument that measures the degree of anxiety. The inventory consists of a self-assessment form containing 21 statements intended to measure 21 different anxiety symptoms. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge.
- The Clinical Global Impressions (CGI) scale. CGI is a 7-scaled evaluation tool that requires the physician to determine the degree of the patient's disease at the time of assessment, in relation to the clinician's previous experience in patients with the same diagnosis. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical sensory room | Active comparator | Other: Sensory roomIn the inpatient ward there is a specifically designed room for calming down which a patient can request access to. In the room there is calming music, soft mats, nature themed wallpaper and calming visual lighting. |
| Virtual sensory room | Experimental | Device: Virtual sensory roomThe patients will have access to wireless virtual reality glasses during a session. The glasses will have a specially made protection that will be disinfected between each user, all users will also have the opportunity to choose a disposable cover for the glasses. The VR glasses are adjustable and adaptable to all types of head sizes and can be used with regular glasses. The application accessable in the VR glasses is called Calm Place, a virtual natural environment with day and night cycles, dynamic weather and associated soundscapes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to one of the two eligible inpatient units
- Age over 18 years
Key exclusion criteria (4 listed)
- Diagnosis of schizophrenia (ICD-10 F20) or schizoaffective disorder (ICD-10 F25)
- Intellectual developmental disorder, organic brain injury or other condition that precludes informed consent
- Active withdrawal symptoms from alcohol or other substances of abuse
- Visual or balance disorder
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 sensory roomA pair of virtual reality glasses (Oculus Go) with installed the program Calm Place, a program designed for anxiety reduction. | Device | Virtual sensory room |
| Sensory roomA room with calming elements that patients can use to feel calm. | Other | Physical sensory room |
Primary outcome
Change on Visual Analogue Scale of anxiety
Time frame: Immediately before and following the first administration of treatment
A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety
8 secondary outcomes
Beck´s Anxiety Scale
Time frame: Once weekly from date of inclusion until the date of discharge up to 3 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS-S)
Time frame: Once weekly from date of inclusion until the date of discharge up to 3 weeks
Use of anxiolytic medication
Time frame: Total use of medication from date of inclusion to date of discharge up to 3 weeks
Clinical Global Impression
Time frame: Once weekly from date of inclusion until the date of discharge up to 3 weeks
Length of stay
Time frame: Length of admission in days from date of inclusion to date of discharge up to a year
Blood pressure
Time frame: Immediately before and following first administration of treatment
Pulse
Time frame: Immediately before and following first administration of treatment
Visual Analogue Scale of anxiety
Time frame: An average of each immediate before and following measure of the administration of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Derived from this study: PubMed 37204858Ilioudi M, Lindner P, Ali L, Wallstrom S, Thunstrom AO, Ioannou M, Anving N, Johansson V, Hamilton W, Falk O, Steingrimsson S. Physical Versus Virtual Reality-Based Calm Rooms for Psychiatric Inpatients: Quasi-Randomized Trial. J Med Internet Res. 2023 May 19;25:e42365. doi: 10.2196/42365.
- Individual participant dataSharing planned: No
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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.
Steinn Steingrimsson, PhD study director
Sahlgrenska Academy
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 sensory room and Sensory room in people with Anxiety State and Depression, run by Vastra Gotaland Region at 1 site in Sweden.
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 4 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: finished, as of the sponsor's last update on 13 May 2021. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Visual Analogue Scale of anxiety (time frame: Immediately before and following the first administration of treatment). 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 NCT03918954, which also lists 1 linked publication.
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 13 May 2021.