Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program
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|ClinicalTrials.gov Identifier: NCT00151554|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : July 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases||Behavioral: ICU-specific information program||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||December 2006|
|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.
- Patient self-reported anxiety [ Time Frame: after admission on standard ward ]
- ICU related discomfort [ Time Frame: after admission on standard ward ]
- Objective health status parameters [ Time Frame: postoperative phase of hospital stay ]
- Overall satisfaction with care [ Time Frame: 3 months after discharge ]
- Quality of life [ Time Frame: 3 months after discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151554
|University Hospital Marburg|
|Marburg, Hessen, Germany, 35033|
|Principal Investigator:||Thomas Neubert, PhD||Stabstelle Pflegeforschung, Universitätsklinikum Marburg|