The online version of this article (doi:10.1186/1471-2253-14-48) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
SF wrote the first draft of the manuscript. All authors contributed equally to the final manuscript and made substantial intellectual contributions. AB, SF, and TRN had the idea for the trial rationale and initiated the trial proposal. All authors were responsible for conception and design of the final study protocol. TRN was the responsible coordinator of the study center in Marburg, AH in Stuttgart, and JB in Halle. RB monitored all participating study centers in regard to compliance to the study protocol. RB, TRN, AH, SF, and AB developed the study intervention. OK planned the statistical analysis and randomization. RB and SF supervised data entry. OK and SF conducted the statistical analysis. All authors read and approved the final manuscript.
Communication and information in order to reduce anxiety in the intensive care unit (ICU) has been described as area needing improvement. Therefore, the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients.
Multicenter, two-armed, non-blinded, parallel-group randomized controlled trial in hospitals in the cities of Marburg, Halle, and Stuttgart (Germany). The trial was performed in cardiac surgery, general surgery, and internal medicine ICUs. Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study (intervention group, n = 104; control group, n = 107). The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts: (1) A more standardized part about predefined ICU specific aspects – mainly procedural, sensory and coping information, and (2) an individualized part about fears and questions of the patient. The control group received a non-specific episodic conversation of similar length additional to standard care. Both conversations took place at the beginning of the ICU stay and lasted 10–15 minutes. Study nurses administered both interventions. The primary outcome ICU-related anxiety (CINT-Score, 0–100 pts., higher scores indicate higher anxiety) was assessed after admission to a regular ward.
The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 (SD 14.4) compared to 20.8 (SD 14.7) and a mean difference of −0.2 (CI 95% -4.5 to 4.1).
A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration. Reduction of anxiety in ICU patients will probably require more continuous approaches to information giving and communication.
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- Does an additional structured information program during the intensive care unit stay reduce anxiety in ICU patients?: a multicenter randomized controlled trial
Thomas R Neubert
- BioMed Central
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