Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT00764933
Status:
COMPLETED
Last Update Posted:
2010-06-03
First Post:
2008-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structured Information During the Intensive Care Unit Stay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-01', 'studyFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient self-reported anxiety', 'timeFrame': 'First three days on ICU and/or within 24 hours after ICU discharge'}], 'secondaryOutcomes': [{'measure': 'Confusion Assessment Method for the ICU (CAM-ICU)', 'timeFrame': 'Within first three days on ICU'}, {'measure': 'Patient self reported health-related quality of life', 'timeFrame': '3 months after discharge from hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['information programme', 'anxiety reduction', 'multicenter trial', 'intensive care', 'critical care'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '25071414', 'type': 'DERIVED', 'citation': 'Fleischer S, Berg A, Behrens J, Kuss O, Becker R, Horbach A, Neubert TR. Does an additional structured information program during the intensive care unit stay reduce anxiety in ICU patients?: a multicenter randomized controlled trial. BMC Anesthesiol. 2014 Jun 28;14:48. doi: 10.1186/1471-2253-14-48. eCollection 2014.'}, {'pmid': '19751500', 'type': 'DERIVED', 'citation': 'Fleischer S, Berg A, Neubert TR, Koller M, Behrens J, Becker R, Horbach A, Radke J, Rothmund M, Kuss O. Structured information during the ICU stay to reduce anxiety: study protocol of a multicenter randomized controlled trial. Trials. 2009 Sep 14;10:84. doi: 10.1186/1745-6215-10-84.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether a structured information program at the beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.', 'detailedDescription': 'The trial is designed as a prospective multicenter randomized controlled trial including an intervention and a control group. The control group receives an unspecific conversation. The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU. Anxiety will be measured with a VAS during ICU stay and with a questionnaire after ICU discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective open heart or abdominal surgery including scheduled ICU stay\n* Heart or abdominal surgery or internal patients with non-scheduled ICU stay\n* Informed consent\n\nExclusion Criteria:\n\n* Reduced sensual perception\n* Cognitive impairment\n* Not able to answer a questionnaire (e.g. illiterate)\n* Lying in the same room with another patient already included'}, 'identificationModule': {'nctId': 'NCT00764933', 'briefTitle': 'Structured Information During the Intensive Care Unit Stay', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay', 'orgStudyIdInfo': {'id': 'PfVMS-T4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Structured information', 'interventionNames': ['Behavioral: Structured information']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'Unspecific conversation', 'interventionNames': ['Other: Unspecific conversation']}], 'interventions': [{'name': 'Structured information', 'type': 'BEHAVIORAL', 'description': 'Participants will receive structured information about their ICU-stay and course of therapy and care. They get information about procedures, sensory impressions and coping strategies. The intervention will last about 10 to 15 minutes depending on the state of the participant.', 'armGroupLabels': ['1']}, {'name': 'Unspecific conversation', 'type': 'OTHER', 'description': 'Participants will receive a short conversation with the study personnel. This conversation will last about 10 to 15 minutes. No specific informations will be given about procedures, sensory impressions or coping strategies. Control intervention is designed to control for personal attention and care.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Sana Herzchirurgische Klinik Stuttgart GmbH', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Marburg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '06097', 'city': 'Halle', 'state': 'SAN', 'country': 'Germany', 'facility': 'Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. phil habil Johann Behrens', 'oldOrganization': 'Martin-Luther-Universität Halle-Wittenberg'}}}}