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Structured Information During the ICU Stay to Reduce Anxiety: Study Trials BioMed Central Study protocol Open Access Structured information during the ICU stay to reduce anxiety: study protocol of a multicenter randomized controlled trial Steffen Fleischer*1, Almuth Berg1, Thomas R Neubert2, Michael Koller3, Johann Behrens1, Ralf Becker2, Annegret Horbach4,5, Joachim Radke6, Mathias Rothmund7 and Oliver Kuss8 Address: 1Institute of Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Germany, 2Department of Nursing Research, University Hospital Giessen and Marburg, Location Marburg, Germany, 3Center for Clinical Trials, University Hospital Regensburg, Germany, 4Sana Herzchirurgische Klinik Stuttgart, Germany, 5Department 4: Health and Social Work, University of Applied Sciences, Frankfurt/ Main, Germany, 6Department of Anesthesiology and Intensive Care Medicine, University Hospital, Martin-Luther-University Halle-Wittenberg, Germany, 7Institute for Theoretical Surgery/Department of Visceral, Thoracic and Vascular Surgery, University Hospital Giessen and Marburg, Location Marburg, Germany and 8Institute of Medical Epidemiology, Biostatistics, and Informatics, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Germany Email: Steffen Fleischer* - [email protected]; Almuth Berg - [email protected]; Thomas R Neubert - [email protected]; Michael Koller - [email protected]; Johann Behrens - [email protected]; Ralf Becker - [email protected]; Annegret Horbach - [email protected]; Joachim Radke - [email protected]; Mathias Rothmund - [email protected]; Oliver Kuss - [email protected] * Corresponding author Published: 14 September 2009 Received: 22 May 2009 Accepted: 14 September 2009 Trials 2009, 10:84 doi:10.1186/1745-6215-10-84 This article is available from: http://www.trialsjournal.com/content/10/1/84 © 2009 Fleischer et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract 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. Discussion: 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. Trial Registration: ClinicalTrials NCT00764933 Page 1 of 9 (page number not for citation purposes) Trials 2009, 10:84 http://www.trialsjournal.com/content/10/1/84 Background cation in an ICU and were able to identify three main ICU stay for ventilated patients is associated with severe issues: "perception of caregivers", "presence" and "strain impairments and limitations of communication. Addi- relief" - whereas the category "strain relief" is mainly made tionally, these patients are restricted regarding their activ- up of the situational information of the patient. This per- ities and ability to participate. These restrictions are ception of successful conscious communication is mainly due to structural and procedural necessities opposed by the notion that communication is always including therapeutic interventions. The patients are not something random and natural [13]. Against the back- only handicapped by their vocal restraints, but also by the ground and as a consequence of Liedtkes [1] results, a con- unknown and unfamiliar situation in the ICU. Nonethe- crete and conscious communication intervention for the less, ventilated patients are able to actively communicate information of the ICU patient and with "strain relief" in with their environment. Research shows that nurse-initi- mind would be necessary. ated nurse-patient communication is lacking in this phase of ventilation [1]. If the nurses are interacting with the Only one randomized controlled study (RCT), could be patient, the interaction is nonverbal and rather instru- found which deals with a information intervention in the mental. With the patient getting more and more awake ICU [14]. For their research approach in cardiac surgery and able to respond, nurse-initiated communication patients, Hwang et al. [14] chose a recorded tape informa- increases [1]. tion from the attending physician which was played to the patients after recovering from anesthesia. The contents of Research into the communication behavior in intensive the 6 to 8 minute recordings included the course as well care units, not limited to ventilated patients, showed as the result of the operation and further treatment plans. interactions and interaction conditions which had pre- The intervention group showed significantly superior val- dominantly been perceived as problematic by patients [2- ues regarding anxiety, tension, depression and pain per- 10]. ICU patients often experience these ineffective com- ception compared to the control group. The results of this munication situations with feelings of anxiety, insecurity study suggest the effectiveness of postoperative situational but also irritation. Particularly ventilated patients evaluate information intervention for a positive influence on psy- the communication during their ventilation as non-suc- chological parameters. Therefore a nursing care informa- cessful [3,10,11]. In this context, Alasad and Ahmad [2] tion program comparable to and modeled on the brief found that communication with patients in ICUs is not medical information is to be tested in the planned trial continuous and strongly depends on the patient's condi- with ICU patients. tion. Intensive care nurses found work with awakened patients being able to communicate verbally as more Trial objective exhausting, as compared to still unconscious patients. The aim of the project is to evaluate the effectiveness of a Here, communication was also not perceived as a possi- structured information program for patients who are stay- bility of informing and supporting the patient. ing in an ICU and thus having an associated induced com- munication restriction. In line with notions of control Similarly, Scheer [12] observed that the nursing staff in theory and nursing theory, the communication of knowl- ICUs often feels overstrained and tends to withdraw from edge is regarded as a means to enhance patients' capacity the patients' bedsides. Similar results were obtained by to understand, classify and predict the many unfamiliar means of a video analysis which investigated the commu- events related to the ICU stay [15-17]. In this way it is not nication and interaction between ventilated patients and only possible to achieve an improvement of the difficult nursing staff in an ICU [1]. This analysis focused on the communication situation, but a cognitive reframing of the patient's remaining possibilities of expression in the dif- anxiety provoking ICU-stay. This can result in an ferent treatment stages taking into account also aspects of increased perceived locus of control and eventually in initiative and responsive communication. As a result, les- stress reduction. sons in specific communicative abilities for nursing staff in intensive care were proposed, as the staff had acted The key study hypothesis is: upon "normal" social communication patterns and had not sufficiently observed the particularities of the setting An information program in the initial stage of treatment [1]. in an ICU alleviates unpleasant experiences related to the ICU stay and thus contributes to an improvement of the The high priority of successful communication with com- patient's situation and of particular aspects of quality of municatively challenged patients, however, is also appre- life, i.e. in relieving anxiety. ciated by the ICU nursing staff [11,13]. In their qualitative study, Usher and Monkley [13] investigated the point of view of nursing staff on successful and effective communi- Page 2 of 9 (page number not for citation purposes) Trials 2009, 10:84 http://www.trialsjournal.com/content/10/1/84 Besides this main point there are also other, secondary Inclusion and exclusion criteria hypotheses particularly assuming effects on individual Cardiac surgery, general surgery and internist patients quality of life 3 months after discharge. with scheduled and unscheduled ICU stay (including High Dependency Units) will be eligible for inclusion in Methods this trial.
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