Structured Information During the Intensive Care Unit Stay
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay|
- Patient self-reported anxiety [ Time Frame: First three days on ICU and/or within 24 hours after ICU discharge ] [ Designated as safety issue: No ]
- Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: Within first three days on ICU ] [ Designated as safety issue: No ]
- Patient self reported health-related quality of life [ Time Frame: 3 months after discharge from hospital ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Behavioral: Structured information
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.
Sham Comparator: 2
Other: Unspecific conversation
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764933
|Sana Herzchirurgische Klinik Stuttgart GmbH|
|Stuttgart, BW, Germany|
|Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg|
|Marburg, HES, Germany|
|Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg|
|Halle, SAN, Germany, 06097|