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Structured Information During the Intensive Care Unit Stay

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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

Study Description
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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.
Study Design
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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

Arms and Interventions
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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.


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00764933


Locations
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Germany
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. phil habil Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov 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