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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.
 
ClinicalTrials.gov Identifier: NCT00764933
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : June 3, 2010
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date June 3, 2010
Study Start Date  ICMJE January 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Patient self-reported anxiety [ Time Frame: First three days on ICU and/or within 24 hours after ICU discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: Within first three days on ICU ]
  • Patient self reported health-related quality of life [ Time Frame: 3 months after discharge from hospital ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Structured Information During the Intensive Care Unit Stay
Official Title  ICMJE A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Anxiety
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Structured information
    Intervention: Behavioral: Structured information
  • Sham Comparator: 2
    Unspecific conversation
    Intervention: Other: Unspecific conversation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2010)
211
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
200
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764933
Other Study ID Numbers  ICMJE PfVMS-T4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. phil habil Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Martin-Luther-Universität Halle-Wittenberg
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE Not Provided
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP