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Structured Information During the Intensive Care Unit Stay

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764933
First Posted: October 2, 2008
Last Update Posted: June 3, 2010
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.
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
  Purpose
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 Intervention
Anxiety Behavioral: Structured information Other: Unspecific conversation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 211
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. phil habil Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00764933     History of Changes
Other Study ID Numbers: PfVMS-T4
First Submitted: October 1, 2008
First Posted: October 2, 2008
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