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Structured Information During the Intensive Care Unit Stay

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764933
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : June 3, 2010
German Federal Ministry of Education and Research
Information provided by:
Martin-Luther-Universität Halle-Wittenberg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Structured information Other: Unspecific conversation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1
Structured information
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
Unspecific conversation
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.

Primary Outcome Measures :
  1. Patient self-reported anxiety [ Time Frame: First three days on ICU and/or within 24 hours after ICU discharge ]

Secondary Outcome Measures :
  1. Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: Within first three days on ICU ]
  2. Patient self reported health-related quality of life [ Time Frame: 3 months after discharge from hospital ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective open heart or abdominal surgery including scheduled ICU stay
  • Heart or abdominal surgery or internal patients with non-scheduled ICU stay
  • Informed consent

Exclusion Criteria:

  • Reduced sensual perception
  • Cognitive impairment
  • Not able to answer a questionnaire (e.g. illiterate)
  • Lying in the same room with another patient already included

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764933

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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
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
German Federal Ministry of Education and Research
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. phil habil Johann Behrens, Martin-Luther-Universität Halle-Wittenberg Identifier: NCT00764933    
Other Study ID Numbers: PfVMS-T4
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: January 2010
Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
information programme
anxiety reduction
multicenter trial
intensive care
critical care