Mental DisordersNCT00184132
The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.
A study testing Psychiatric intensive care unit in Norwegian home style and Psychiatric intensive care unit sparsely furnished and not decorated in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of the study is to compare effects of treatment of patients acutely admitted to a Psychiatric Intensive Care Unit (PICU) with either a sparsely decorated interior or interior decorations like an ordinary, Norwegian home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Psychiatric intensive care unit in Norwegian home style and Psychiatric intensive care unit sparsely furnished and not decorated
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2000to Jun 2010
- 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
- All patients acutely admitted to the PICU, St. Olavs Hospital, Østmarka dep.
Who cannot join
- Patients with dementia or mental retardation to an extensive degree.
- Patients not speaking Norwegian or English
Trial locations and contacts
1 site in 1 country.
Norway1 site
Østmarka Psychiatric Department, St. Olavs Hospital
Trondheim, 7441
About this study
The purpose of the study is to compare effects of treatment of patients acutely admitted to a Psychiatric Intensive Care Unit (PICU) with either a sparsely decorated interior or interior decorations like an ordinary, Norwegian home.
Read the detailed description
The PICU in Østmarka psychiatric department, St. Olavs Hospital contains 2 identical parts. Each part contains 2 beds. The PICU had a traditional sparsely decorated interior. In cooperation with architects and the county building authorities one of the parts were redecorated to an interior like an ordinary Norwegian home. All patients admitted the the PICU were semi-randomized to either traditional or "Norwegian home" interior decorations. Symptoms, behaviour, and treatment were evaluated at admittance, day 3 and discharge from the PICU
- Conditions
- Mental Disorders
- Being tested
- Psychiatric intensive care unit in Norwegian home style, Psychiatric intensive care unit sparsely furnished and not decorated
- Keywords
- Intensive care units, Emergency services, psychiatric, Interior Design and Furnishings, Intensive Care
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric intensive care unit in Norwegian home styleProcedure or surgery
Psychiatric intensive care unit sparsely furnished and not decoratedProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Norwegian home style ward | Experimental | The walls received wainscots, colourful wallpaper and paintings; the ceilings were lowered and had multiple lighting spots, the windows tasteful curtains; we put wardrobes, chairs, flowers and personal items in the patient rooms; and Italian ceramic tile covered the entire bathroom Receives: Procedure: Psychiatric intensive care unit in Norwegian home style |
| sparsely furnished ward | Active comparator | traditional interior design and furnishings. The rooms had sparse furniture, walls in grey colours lacking pictures, no window curtains, single lamps in the ceiling 4 m high, bathroom with grey, laminated paint all over, and patient rooms with a single bed and a chair of metal tubes Receives: Procedure: Psychiatric intensive care unit sparsely furnished and not decorated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in days
Measured: 1 month
Scores on general psychiatric rating scale
Positive and Negative Syndrome Scale (PANSS)
Measured: 3 days
Scores on violent or threatening incidents
recorded with Staff Observation Aggression ScaleRevised (SOAS-R)
Measured: 3 days
Secondary outcomes (1)
Therapeutic steps daily
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2000
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, County of South Trøndelag
- Responsible party
- Sponsor
- Investigators
- Olav M Linaker, Professor, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184132
- Sponsor's protocol ID
- AEV-00
- Status last verified
- Mar 2017
- First submitted
- 9 Sep 2005
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaaler AE, Morken G, Linaker OM. Effects of different interior decorations in the seclusion area of a psychiatric acute ward. Nord J Psychiatry. 2005;59(1):19-24. doi: 10.1080/08039480510018887.
PubMed 16195094Vaaler AE, Iversen VC, Morken G, Flovig JC, Palmstierna T, Linaker OM. Short-term prediction of threatening and violent behaviour in an Acute Psychiatric Intensive Care Unit based on patient and environment characteristics. BMC Psychiatry. 2011 Mar 18;11:44. doi: 10.1186/1471-244X-11-44.
PubMed 21418581Flovig JC, Vaaler AE, Morken G. Effects of legal and illegal use of benzodiazepines at acute admission to a psychiatric acute department. BMC Res Notes. 2010 Oct 19;3:263. doi: 10.1186/1756-0500-3-263.
PubMed 20958975
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT00184132
- Acronym / sponsor ID
- AEV-00
- Conditions
- Mental Disorders
- Keywords
- Intensive care units, Emergency services, psychiatric, Interior Design and Furnishings, Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, County of South Trøndelag
- Study start
- Nov 2000 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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.
The purpose of the study is to compare effects of treatment of patients acutely admitted to a Psychiatric Intensive Care Unit (PICU) with either a sparsely decorated interior or interior decorations like an ordinary, Norwegian home.
Detailed description
The PICU in Østmarka psychiatric department, St. Olavs Hospital contains 2 identical parts. Each part contains 2 beds. The PICU had a traditional sparsely decorated interior. In cooperation with architects and the county building authorities one of the parts were redecorated to an interior like an ordinary Norwegian home. All patients admitted the the PICU were semi-randomized to either traditional or "Norwegian home" interior decorations. Symptoms, behaviour, and treatment were evaluated at admittance, day 3 and discharge from the PICU
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norwegian home style ward | Experimental | Procedure: Psychiatric intensive care unit in Norwegian home styleThe walls received wainscots, colourful wallpaper and paintings; the ceilings were lowered and had multiple lighting spots, the windows tasteful curtains; we put wardrobes, chairs, flowers and personal items in the patient rooms; and Italian ceramic tile covered the entire bathroom |
| sparsely furnished ward | Active comparator | Procedure: Psychiatric intensive care unit sparsely furnished and not decoratedtraditional interior design and furnishings. The rooms had sparse furniture, walls in grey colours lacking pictures, no window curtains, single lamps in the ceiling 4 m high, bathroom with grey, laminated paint all over, and patient rooms with a single bed and a chair of metal tubes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients acutely admitted to the PICU, St. Olavs Hospital, Østmarka dep.
Key exclusion criteria (2 listed)
- Patients with dementia or mental retardation to an extensive degree.
- Patients not speaking Norwegian or English
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 |
|---|---|---|
| Psychiatric intensive care unit in Norwegian home style | Procedure or surgery | Norwegian home style ward |
| Psychiatric intensive care unit sparsely furnished and not decorated | Procedure or surgery | sparsely furnished ward |
Primary outcome
Length of stay in days
Time frame: 1 month
Scores on general psychiatric rating scale
Time frame: 3 days
Positive and Negative Syndrome Scale (PANSS)
Scores on violent or threatening incidents
Time frame: 3 days
recorded with Staff Observation Aggression ScaleRevised (SOAS-R)
1 secondary outcome
Therapeutic steps daily
Time frame: 3 days
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 Mar 2017.
- Results publication: PubMed 16195094Vaaler AE, Morken G, Linaker OM. Effects of different interior decorations in the seclusion area of a psychiatric acute ward. Nord J Psychiatry. 2005;59(1):19-24. doi: 10.1080/08039480510018887.
- Derived from this study: PubMed 21418581Vaaler AE, Iversen VC, Morken G, Flovig JC, Palmstierna T, Linaker OM. Short-term prediction of threatening and violent behaviour in an Acute Psychiatric Intensive Care Unit based on patient and environment characteristics. BMC Psychiatry. 2011 Mar 18;11:44. doi: 10.1186/1471-244X-11-44.
- Derived from this study: PubMed 20958975Flovig JC, Vaaler AE, Morken G. Effects of legal and illegal use of benzodiazepines at acute admission to a psychiatric acute department. BMC Res Notes. 2010 Oct 19;3:263. doi: 10.1186/1756-0500-3-263.
- 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.
Olav M Linaker, Professor study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric intensive care unit in Norwegian home style and Psychiatric intensive care unit sparsely furnished and not decorated in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 2 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 Mar 2017. 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 Norway. 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?
Length of stay in days (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT00184132, which also lists 3 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 13 Mar 2017.