Clinical trial NCT00764933: Structured Information During the Intensive Care Unit Stay
Official title: A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: information programme
anxiety reduction
multicenter trial
intensive care
critical care
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2008-10-02
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Patient self-reported anxiety
timeFrame: First three days on ICU and/or within 24 hours after ICU discharge
Secondary outcomes:
measure: Confusion Assessment Method for the ICU (CAM-ICU)
timeFrame: Within first three days on ICU
measure: Patient self reported health-related quality of life
timeFrame: 3 months after discharge from hospital
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Sana Herzchirurgische Klinik Stuttgart GmbH
state: BW
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg
state: HES
city: Halle
country: Germany
facility: Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
state: SAN
Study officials:
References:
citation: Fleischer S, Berg A, Behrens J, Kuss O, Becker R, Horbach A, Neubert TR. Does an additional structured information program during the intensive care unit stay reduce anxiety in ICU patients?: a multicenter randomized controlled trial. BMC Anesthesiol. 2014 Jun 28;14:48. doi: 10.1186/1471-2253-14-48. eCollection 2014.
citation: Fleischer S, Berg A, Neubert TR, Koller M, Behrens J, Becker R, Horbach A, Radke J, Rothmund M, Kuss O. Structured information during the ICU stay to reduce anxiety: study protocol of a multicenter randomized controlled trial. Trials. 2009 Sep 14;10:84. doi: 10.1186/1745-6215-10-84.