Structured information during the ICU stay to reduce anxiety: study protocol of a multicenter randomized controlled trial.
BACKGROUND
ICU stay is often associated with negative experiences for the individual patient. Many patients are disabled and their communication is restricted during the ICU stay. Specific information on procedures, sensations and coping behavior are thought to reduce anxiety on the ICU. Until now information programs to reduce anxiety were mainly delivered preoperatively, completely neglecting informational needs of non-elective ICU patients.


METHODS
The trial is designed as a prospective multicenter randomized controlled trial in the cities of Marburg, Halle and Stuttgart. Elective and non-elective ICU patients will be included. The trial includes an intervention and a control group on the ICU. The control group receives a trivial conversation without any ICU-specific information. The intervention group receives an information program with specific procedural, sensory and coping information about their ICU stay. Both conversations take place in the ICU and are planned to take about 10 minutes.


CONCLUSIONS
In contrast to former trials on information programs on the ICU-stay our intervention will take place in the ICU itself. This approach will ensure to compensate for memory effects due to anesthesia or preoperative stress. Further the results will be applicable to non-elective ICU-patients.


BACKGROUND
ClinicalTrials NCT00764933.
Fleischer
Steffen
S
Institute of Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Germany. steffen.fleischer@medizin.uni-halle.de
Berg
Almuth
A
Neubert
Thomas R
TR
Koller
Michael
M
Behrens
Johann
J
Becker
Ralf
R
Horbach
Annegret
A
Radke
Joachim
J
Rothmund
Mathias
M
Kuss
Oliver
O
D001007:Anxiety / Q000517:prevention & control*; D002985:Clinical Protocols; D006801:Humans; D007362:Intensive Care Units