Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Philipps University Marburg Medical Center Pflegeverbund Mitte-Süd Stabstelle Pflegeforschung Institut für Theoretische Chirurgie Klinik für Herzchirurgie Klinik für VTG-Chirurgie |
---|---|
Information provided by: | Philipps University Marburg Medical Center |
ClinicalTrials.gov Identifier: | NCT00151554 |
According to current evidence and psychological theorizing, the provision of information seems to be a promising way to reduce the anxiety of patients that is related to their scheduled ICU stay. An ICU-specific information program will be investigated in a randomized controlled clinical trial involving 120 patients undergoing elective open heart surgery and 20 patients undergoing abdominal surgery. It is expected that the patients in the test group will experience less anxiety and ICU related discomfort than patients in the control group.
Condition | Intervention | Phase |
---|---|---|
Heart Diseases |
Behavioral: ICU-specific information program |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Active Control, Single Group Assignment |
Official Title: | Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2006 |
Objective: According to current evidence and psychological theorizing the provision of information seems to be a promising way to reduce anxiety of patients. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU-specific information could have a high clinical impact. For this reason this study will evaluate the efficacy of an ICU-specific information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for ICU stay.
Methods: The trial is designed as a prospective randomized controlled trial including an intervention and a control group. The control group receives the standard preparation currently conducted by surgeons and anesthesists. The intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the ICU. In addition the moderating effect of certain personality characteristics (need for cognition, high trait anxiety) will be investigated to identify groups of patients who benefit most from the information program.
Expected Results: A clinically relevant difference in anxiety and unpleasant experiences related to the ICU is expected after discharge from the ICU. Power calculation (alpha = 0.05; beta = 0.20; delta = 8.50 score points) resulted in a required sample size of N = 120 cardiac surgical patients (n = 60 vs. n = 60). Furthermore, N = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10).
Conclusion: The proposed study promises to strengthen evidence on the effects of a specific, concise information program and thus should contribute to evidence based nursing (EBN).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steffen Fleischer, Dipl.-PGW | +49 6421 286 66759 | steffen.fleischer@staff.uni-marburg.de |
Contact: Berg Almuth, Dipl.-PGW | +49 6421 286 66759 | almuth.berg@staff.uni-marburg.de |
Germany, Hessen | |
University Hospital Marburg | Recruiting |
Marburg, Hessen, Germany, 35033 | |
Contact: Thomas Neubert, PhD +49 6421 286 3285 neutert@staff.uni-marburg.de | |
Principal Investigator: Thomas Neubert, PhD |
Principal Investigator: | Thomas Neubert, PhD | Stabstelle Pflegeforschung, Universitätsklinikum Marburg |
Study ID Numbers: | PflegeverbundMarburg2, BMBF grant 01GT0303 |
Study First Received: | September 7, 2005 |
Last Updated: | July 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00151554 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Anxiety Intensive Care Unit (ICU) Preoperative Information Randomized Controlled Trial (RCT) Chronic heart disease |
Heart Diseases |
Cardiovascular Diseases |