Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial|
- Patient self-reported anxiety [ Time Frame: after admission on standard ward ] [ Designated as safety issue: No ]
- ICU related discomfort [ Time Frame: after admission on standard ward ] [ Designated as safety issue: No ]
- Objective health status parameters [ Time Frame: postoperative phase of hospital stay ] [ Designated as safety issue: No ]
- Overall satisfaction with care [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
|No Intervention: Control group|
|Experimental: Intervention group||
Behavioral: ICU-specific information program
The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU in addition to standard information given by surgeons and anesthetists.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151554
|University Hospital Marburg|
|Marburg, Hessen, Germany, 35033|
|Principal Investigator:||Thomas Neubert, PhD||Stabstelle Pflegeforschung, Universitätsklinikum Marburg|