Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program
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Purpose
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 |
|---|---|
|
Heart Diseases |
Behavioral: ICU-specific information program |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 140 |
| Study Start Date: | February 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elective open heart or abdominal surgery including scheduled ICU stay
- Informed consent
Exclusion Criteria:
- Elective surgery without ICU stay
- Informed consent denied
Contacts and Locations| Germany | |
| University Hospital Marburg | |
| Marburg, Hessen, Germany, 35033 | |
| Principal Investigator: | Thomas Neubert, PhD | Stabstelle Pflegeforschung, Universitätsklinikum Marburg |
More Information
Publications:
| Responsible Party: | Dr. Thomas R. Neubert, Philipps University Marburg Medical Center |
| ClinicalTrials.gov Identifier: | NCT00151554 History of Changes |
| Other Study ID Numbers: | PflegeverbundMarburg2, BMBF grant 01GT0303 |
| Study First Received: | September 7, 2005 |
| Last Updated: | July 28, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Philipps University Marburg Medical Center:
|
Anxiety Intensive Care Unit (ICU) Preoperative Information Randomized Controlled Trial (RCT) Chronic heart disease |
Additional relevant MeSH terms:
|
Anxiety Disorders Heart Diseases Mental Disorders Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013