Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00184132
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay in days', 'timeFrame': '1 month'}, {'measure': 'Scores on general psychiatric rating scale', 'timeFrame': '3 days', 'description': 'Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'Scores on violent or threatening incidents', 'timeFrame': '3 days', 'description': 'recorded with Staff Observation Aggression ScaleRevised (SOAS-R)'}], 'secondaryOutcomes': [{'measure': 'Therapeutic steps daily', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive care units', 'Emergency services, psychiatric', 'Interior Design and Furnishings', 'Intensive Care'], 'conditions': ['Mental Disorders']}, 'referencesModule': {'references': [{'pmid': '16195094', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '21418581', 'type': 'DERIVED', 'citation': 'Vaaler 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.'}, {'pmid': '20958975', 'type': 'DERIVED', 'citation': 'Flovig 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients acutely admitted to the PICU, St. Olavs Hospital, Østmarka dep.\n\nExclusion Criteria:\n\n* Patients with dementia or mental retardation to an extensive degree.\n* Patients not speaking Norwegian or English'}, 'identificationModule': {'nctId': 'NCT00184132', 'briefTitle': 'The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.', 'orgStudyIdInfo': {'id': 'AEV-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norwegian home style ward', 'description': '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', 'interventionNames': ['Procedure: Psychiatric intensive care unit in Norwegian home style']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sparsely furnished ward', 'description': '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', 'interventionNames': ['Procedure: Psychiatric intensive care unit sparsely furnished and not decorated']}], 'interventions': [{'name': 'Psychiatric intensive care unit in Norwegian home style', 'type': 'PROCEDURE', 'armGroupLabels': ['Norwegian home style ward']}, {'name': 'Psychiatric intensive care unit sparsely furnished and not decorated', 'type': 'PROCEDURE', 'armGroupLabels': ['sparsely furnished ward']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7441', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Østmarka Psychiatric Department, St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Olav M Linaker, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'County of South Trøndelag', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}