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Sponsors and Collaborators: |
Martin-Luther-Universität Halle-Wittenberg German Federal Ministry of Education and Research |
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Information provided by: | Martin-Luther-Universität Halle-Wittenberg |
ClinicalTrials.gov Identifier: | NCT00764933 |
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 |
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Anxiety |
Behavioral: Structured information Other: Unspecific conversation |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment |
Official Title: | A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay |
Estimated Enrollment: | 200 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Structured information
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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.
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2: Sham Comparator
Unspecific conversation
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas R Neubert, Dr. | +49 6421 5863285 | neubertt@med.uni-marburg.de |
Contact: Steffen Fleischer, Dipl. PGw | +49 345 557 4133 | steffen.fleischer@medizin.uni-halle.de |
Germany, BW | |
Sana Herzchirurgische Klinik Stuttgart GmbH | Recruiting |
Stuttgart, BW, Germany | |
Contact: Annegret Horbach, Dipl. PGw +49 345 557 5428 annegret.horbach@gmx.de | |
Sub-Investigator: Joachim Gerd Rein, Prof. Dr. | |
Principal Investigator: Annegret Horbach, Dipl. PGw | |
Sub-Investigator: Claude Krier, Prof. Dr. | |
Germany, HES | |
Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg | Recruiting |
Marburg, HES, Germany | |
Contact: Ralf Becker, Dipl. PGw +49 6421 5862222 ralf.becker@med.uni-marburg.de | |
Principal Investigator: Thomas R Neubert, Dr. | |
Sub-Investigator: Matthias Rothmund, Prof. Dr. | |
Sub-Investigator: Rainer Moosdorf, Prof. Dr. | |
Germany, SAN | |
Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg | Recruiting |
Halle, SAN, Germany, 06097 | |
Contact: Steffen Fleischer, Dipl. PGw +49 345 5574133 steffen.fleischer@medizin.uni-halle.de | |
Contact: Stephan Wendroth, Dipl. Psych. +49 345 5572111 stephan.wendroth@medizin.uni-halle.de | |
Principal Investigator: Johann Behrens, Prof. Dr. | |
Sub-Investigator: Joachim Radke, Prof. Dr. |
Responsible Party: | Martin-Luther-Universität Halle-Wittenberg ( Prof. Dr. phil habil Johann Behrens ) |
Study ID Numbers: | PfVMS-T4 |
Study First Received: | October 1, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00764933 |
Health Authority: | Germany: Federal Ministry of Education and Research |
information programme anxiety reduction multicenter trial intensive care critical care |