Structured Information During the Intensive Care Unit Stay - Full Text View

Sponsors and Collaborators:	Martin-Luther-Universität Halle-Wittenberg German Federal Ministry of Education and Research
Information provided by:	Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:	NCT00764933

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

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: Within first three days on ICU ] [ Designated as safety issue: No ]
Patient self reported health-related quality of life [ Time Frame: 3 months after discharge from hospital ] [ Designated as safety issue: No ]

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
1: Experimental 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.
2: Sham Comparator 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764933

Contacts

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

Locations

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.

Sponsors and Collaborators

Martin-Luther-Universität Halle-Wittenberg

German Federal Ministry of Education and Research

More Information

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

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:

information programme
anxiety reduction
multicenter trial
intensive care
critical care

ClinicalTrials.gov processed this record on January 13, 2009